Enforcement Report - Week of November 14, 2012
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Event Detail
| Event ID | 63103 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Zimmer, Inc. |
| City | Warsaw |
| State | IN |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-04 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Alloclassic SL Shaft | Item 2839, 2840, 2841, 2842, 2843, 2844, 2845, 2846, 2847, 2848, 2949, 2851, 2852, 2883, 2884, 2885, 2886, and 2887 Lots: 2359249, 2359251, 2359251, 2368739, 2413914, 2413914, 2426010, 2526138, 2335608, 2381324, 2387449, 2388541, 2401237, 2401237, 2492774, 2523553, 2355767, 2355767, 2361511, 2361511, 2371517, 2376476, 2440672, 2453100, 2479736, 2498363, 2529208, 2303302, 2347856, 2355765, 2355765, 2428247, 2428247, 2446699, 2456353, 2497037, 2506067, 2506067, 2509374, 2517494, 2316056, 2326792, 2335862, 2355428, 2370478, 2376478, 2382854, 2388539, 2391204, 2428742, 2431991, 2439733, 2453093, 2301633, 2343382, 2363829, 2363829, 2363829, 2370490, 2492887, 2513725, 2513725, 2513725, 2515404, 2515404, 2517796, 2529231, 2319316, 2340681, 2345324, 2359179, 2359179, 2413790, 2432646, 2479750, 2501280, 2509376, 2509376, 2509378, 2510392, 2510392, 2303201, 2333704, 2340906, 2368928, 2375002, 2388530, 2403651, 2445551, 2471087, 2507375, 2511623, 2523569, 2345382, 2396573, 2428657, 2432681, 2464083, 2469537, 2475899, 2529943, 2421855, 2421855, 2437494, 2437494, 2475746, 2475746, 2526284, 2391015, 2391015, 2391015, 2390171, 2418766, 2397095, 2399625, 2352268, 2406373, 2406373, 2437316, and 2518394 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1355 | Z-0210-2013 |
| Biolox® delta Ceramic Femoral Head Rx only, sterile | REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04. | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 2544 | Z-0211-2013 |
| Biolox® Option Ceramic Femoral Head System Rx, sterile | REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01. | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 88 | Z-0212-2013 |
| Wagner SL Revision Stem, uncemented Sterile | REF Numbers: 01.00101.914, 01.00101.915, 01.00101.916, 01.00101.917, 01.00101.918, 01.00102.217, 01.00102.219, 01.00102.221, 01.00102.619, 01.00102.620, 01.00102.621, 01.00102.622, 01.00103.015, 01.00103.017, 01.00103.021, 01.00103.025, 30.00.89.160, and 30.00.89.190. | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 87 | Z-0213-2013 |
| Alloclassic® SL-Offset Stem sterile, Rx | REF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090. | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 126 | Z-0214-2013 |
| Metasul® LDH® Head Rx Sterile | REF Numbers: 01.00181.380, 01.00181.400, 01.00181.420, 01.00181.440, 01.00181.460, 01.00181.480, 01.00181.500, 01.00181.520, 01.00181.540, 01.00181.560, 01.00181.580, 01.00181.600, Lots:2336407, 2384226, 2417501, 2379463, 2414200, 2435636, 2437758, 2437758, 2439049, 2318066, 2318066, 2318066, 2337823, 2341591, 2341591, 2350267, 2350642, 2356116, 2379464, 2393154, 2393154, 2407029, 2417505, 2417505, 2334410, 2337816, 2337817, 2342259, 2350644, 2356119, 2356129, 2357620, 2357620, 2367367, 2414126, 2417566, 2431247, 2458307, 2470473, 2314684, 2330846, 2330846, 2331024, 2331024, 2331024, 2336380, 2337812, 2341474, 2341474, 2341474, 2342282, 2343844, 2344862, 2345939, 2374886, 2384620, 2398703, 2414135, 2419493, 2421904, 2431254, 2452258, 2470507, 2320781, 2320781, 2320781, 2337810, 2345946, 2356142, 2356142, 2356155, 2374303, 2378382, 2381628, 2388393, 2395787, 2403721, 2406900, 2431262, 2439060, 2442487, 2332977, 2341611, 2341613, 2343332, 2343332, 2344271, 2346316, 2350291, 2350291, 2357379, 2361010, 2367418, 2367418, 2367426, 2370634, 2374371, 2404509, 2423600, 2424387, 2426405, 2491198, 2504866, 2320794, 2320794, 2320794, 2332984, 2349179, 2352519, 2352530, 2374377, 2377619, 2377620, 2380655, 2380656, 2380656, 2380656, 2383410, 2383410, 2390934, 2417553, 2433540, 2437127, 2453492, 2341639, 2344273, 2344274, 2344274, 2345961, 2355663, 2357626, 2367445, 2369446, 2378396, 2342292, 2342292, 2345963, 2350422, 2357629, 2330839, 2345965, 2353077, 2353077, 2353078, 2353078, 2353078, 2361032, 2361032, and 2481362 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1739 | Z-0215-2013 |
| Metasul® Durom® Femoral component Sterile, Rx | REF Numbers: 01.00211.140, 01.00211.144, 01.00211.152, 01.00211.154. 01.00211.156, 01.00211.158, and 01.00211.160. Lot: 2367454, 2367454, 2367454, 2367454, 2367455, 2367455, 2374382, 2374382, 2374382, 2374382, 2381632, 2381632, 2381634, 2381634, 2409055, 2414048, 2397713, 2397713, 2417888, 2380622, 2380622, 2388389, 2388389, 2388389, 2453506, 2422704, 2375235, 2375235, 2375235, 2394700, and 2508571 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 209 | Z-0216-2013 |
| MS-30® Stem | REF Numbers: 01.00351.005, 01.00351.006, lots 2330077, 2397912 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 30 | Z-0217-2013 |
| MS-30® Distal centralizer, cemented, sterile, Rx | REF Numbers: 01.00351.005, 01.00351.006, 01.00351.014, 01.00351.214, 01.00351.216, 01.00351.416, 01.00351.620, 01.00356.008, 01.00356.010.Lot 2330077, 2397912, 2319413, 2280640, 2386348, 2399448, 2389980, 2389980, 2389980, 2389980, 2426020, and 2430035. | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 58 | Z-0218-2013 |
| MS-30® Proximal positioner | REF Number: 01.00351.265, lot 237973 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 5 | Z-0219-2013 |
| Fitmore" Hip Stem | REF Numbers: 01.00551.102, 01.00551.103, 01.00551.104, 01.00551.106, 01.00551.108, 01.00551.109, 01.00551.110, 01.00551.111, 01.00551.112, 01.00551.201, 01.00551.202, 01.00551.203, 01.00551.204, 01.00551.205, 01.00551.206, 01.00551.207, 01.00551.208, 01.00551.209, 01.00551.210, 01.00551.211, 01.00551.301, 01.00551.302, 01.00551.303, 01.00551.307, 01.00551.308, 01.00551.309, 01.00551.312, 01.00551.313, 00551.402, 00551.405, 00551.407, 00551.408, 00551.409, and 00551.411. Lot: 2492112, 2405383, 2461916, 2486221, 2486734, 2414003, 2379860, 2384352, 2382041, 2406708, 2486291, 2458770, 2479902, 2508062, 2381041, 2486227, 2384141, 2463958, 2476244, 2375830, 2455461, 2470164, 2493934, 2496756, 2376419, 2494086, 2496005, 2528591, 2376542, 2478039, 2500720, 2507124, 2376544, 2461922, 2495240, 2376606, 2384344, 2478043, 2476248, 2478878, 2479894, 2490109, 2489434, 2493749, 2389960, 2478868, 2476256, 2478035, 2397744, 2493741, 2516631, 2398158, 2478724, 2411541, 2407956, 2401609, 2401590, 2402542, 2402544, 2401623, and 2405399 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1190 | Z-0220-2013 |
| Wagner cone Prosthesis, uncemented, sterile, Rx | REF Numbers: 01.00561.214, 01.00561.215, 01.00561.222, 01.00561.313, 01.00561.314, 01.00561.316, 01.00561.317, 01.00561.318, 01.00561.319, and 01.00561.321 Lot:2323157, 2411401, 2505266, 2352457, 2352457, 2323311, 2381296, 2446509, 2336139, 2451855, 2397244, 2451874, 2459988, 2517770, 2528611, 2455390, 2336084, 2413210 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 56 | Z-0221-2013 |
| CoCr Head, sterile, Rx | REF Numbers: 01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, and 01.01012.388 Lot2369409, 2435773, 2448280, 2480485, 2480485, 2397348, , 2402739, 2412633, , 2420719, 2481695, 2520521, 2333576, 2354292, 2369416, 2398778, 2412631, 2447614, 2462604, 2484118, 2498778, 2501857, 2524940, 2524941, 2527698, 2531506, 2531507, 2330195, 2341655, 2448278, 2482086, 2512070, 2518101, 2490816, and 2498784 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1000 | Z-0222-2013 |
| Anatomical Shoulder" Humeral stem | REF Numbers: 01.04201.072, 01.04201.092, 01.04201.102, 01.04201.122, 01.04201.142, 01.04211.072, 01.04211.092, 01.04211.122, and 01.04211.142 Lot 2333904, 2403849, 2416919, 2443150, 2327341, 2452413, 2320506, 2323574, 2364979, 2373235, 2406171, 2416913, 2438286, 2485091, 2331445, 2357957, 2436420, 2440113, 2470299, 2492996, 2320516, 2334543, 2387483, 2411827, 2421859, 2441600, 2511328, . | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 260 | Z-0223-2013 |
| Anatomical Shoulder" Fracture Humeral stem | REF Numbers: 01.04207.072, 01.04207.082, 01.04207.092, 01.04207.112, 01.04207.132, 01.04207.142, 01.04217.072, and 01.04217.132. Lot 2360479, 2373842, 2331163, 2401526, 2458833, 2360473, 2451660, 2387138, 2521377, 2342166, 2455419, 2342646, 2436406, 2362563, 2413744, 2423092, 2423094, 2472576, 2433869, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 139 | Z-0224-2013 |
| Anatomical Shoulder" Humeral Head | REF Numbers: 01.04212.400, 01.04212.420, 01.04212.440, 01.04212.460, 01.04212.480, 01.04212.500, 01.04213.480, and 01.04213.520. LotsLots: 2335921, 2388114, 2475819, 2475819, , 2444895, 2485536, 2397602, 2437195, 2485540, 2397014, 2408970, 2483098, 2370444, 2437201, 2458785, 2458785, 2323268, 2434637, 2334433, 2473843, 2530732, 2336444 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 224 | Z-0225-2013 |
| zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405 | REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474. | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 164 in USA | Z-0226-2013 |
| Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem | REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901, 2435527, 2398475 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 45 USA | Z-0227-2013 |
| Zimmer Inverse/Reverse Screw system, | REF Numbers: . 01.04223.018, 01.04223.024, 027, 030, 033, 036, 042 Lot 2398030, 2430525, 2384923, 2390913, 2396961, 2399397, 2416652, 2424581, 2430509, 2449770, 2497224, 2383780, 2430522, 2430523, 2430523, 2477654, 2484611, 2383751, 2396967, 2399398, 2416653, 2416653, 2422337, 2429084, 2447019, 2463617, 2521820, 2349258, 2383781, 2388857, 2420337, 2428101, 2447022, 2521822, 2383794, 2385133, 2387452, 2390941 , | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 45 USA | Z-0228-2013 |
| Anatomical Shoulder" Inverse Humeral Cup | REF Numbers: 01.04223.100, 01.04223.106, 01.04223.111, 01.04223.121, 01.04223.190, and 01.04223.196.Lot 2310656, 2429295, 2468509, 2310648, 2410046, 2486362, 2474203, 2317777 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 66 | Z-0229-2013 |
| Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx | REF Numbers: 01.04223.200 and 01.04223.236 2313338, 2314443, 2318819, 2331464, 2342906, 2343151, 2346399, 2368714, 2387755, 2425692, 2468583, 2468587, 2471765, 2503386, 2516402 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 228 | Z-0230-2013 |
| Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx | REF Numbers: 01.04223.360, 01.04223.366, 01.04223.400, 01.04223.403, and 01.04223.406 Lot:2330423, 2337486, 2503675, 2335914, 2324383, 2395586, 2405596, 2465511, 2309008, 2309008, 2309008, 2446964, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 74 | Z-0231-2013 |
| Anatomical Shoulder" Ball taper for humeral stem | REF Numbers: 01.04227.102, Lot:2350372, 2381792, 2398201, 2452078, 2460783 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 54 | Z-0232-2013 |
| Anatomical Shoulder" Fracture Humeral Head | REF Numbers: 01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485 Lot 2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, 2441471 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 26 | Z-0233-2013 |
| CLS Stem | REF Numbers: 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125 Lot 2397894, 2393484, 2480480, 2439729, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 18 | Z-0234-2013 |
| Original M.E. Mueller" Low Profile Cup Sterile, Rx | REF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 6 | Z-0235-2013 |
| Dynesys® Set screw M6 | REF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 58 | Z-0236-2013 |
| Dynesys® Universal spacer 6-45 | REF Number: 01.03710.645, Lot 2323776, 2340853, 2347195, 2347196, 2349405, 2352968, 2361598, 2363757, 2368549, 2371803, 2374584, 2374695, 2390243, 2390244, 2392322, 2394946, 2395677, 2410170, 2410171, 2413068, 2414198, 2417869, 2419315, 2419317, 2424170, 2430156, 2439598, 2449297, 2452033, 2454477, 2455648, 2455649, 2469131, 2469132, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 5069 | Z-0237-2013 |
| Dynesys® L.I.S. Stabilizing cord Rx, Sterile | REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 973 | Z-0238-2013 |
| Dynesys® Revision + set screw | REF Numbers: 01.03716.035, 01.03716.040, 01.03716.045, 01.03716.050, 01.03716.435, 01.03716.440, 01.03716.445, 01.03716.450, 01.03716.455 and 01.03717.250 Lot: 2368864, 2344115, 2367073, 2396142, 2334238, 2444021, 2377110, 2305486, 2377111, 2323497, 2389720, 2403550, 2433036, 2444022, 2298967, 2305536, 2348795, 2358159, 2368866, 2368867, 2389721, 2394352, 2449099, 2368870, 2441343, 2367060, 2367062, 2373095, 2373097 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1575 | Z-0239-2013 |
| Dynesys® HA Pedicle + set screw | REF Numbers: 01.03756.040, 01.03756.050, 01.03756.440, 01.03756.445, 01.03756.450, 01.03756.455, 01.03757.235, 01.03757.240, 01.03757.245, 01.03757.250, 01.03757.255, 01.03758.040, 01.03758.050 and 01.03758.055 Lot: 2399360, 2502246, 2519160, 2323382, 2399361, 2459377, 2500751, 2383797, 2425044, 2449147, 2373116, 2411907, 2323399, 2344133, 2344133, 2426558, 2359295, 2426560, 2456268, 2502250, 2323446, 2488882, 2444047, 2323449, 2433071, 2323450, . | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1247 | Z-0240-2013 |
| DTO" Implant | REF Numbers: 01.03791.050, 01.03791.060, and 01.03791.080 Lot: 2417930, 2417948, 2417950, 2417956, 2429074, 2432771, 2462074, 2512965, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | Z-0241-2013 | |
| Dynesys® Top-Loading System Cannulated Pedicle + Set Screw | REF Numbers: 01.03915.245, 01.03916.055, 01.03916.435, 01.03916.440, 01.03916.445, 01.03916.450, 01.03916.455, 01.03917.235, 01.03917.245, 01.03917.250, 01.03917.255, 01.03918.040, 01.03918.045, 01.03918.055, 01.03955.235, 01.03955.245, 01.03955.255, 01.03956.035, 01.03956.435, 01.03956.440, 01.03956.450, 01.03957.240, 01.03957.250, 01.03957.255, 01.03958.045 and 01.03958.050. Lot:2443724, 2443727, 2443738, 2443740, 2443750, 2443751, 2443770, 2449369, 2449373, 2449374, 2449375, 2449416, 2459041, 2459046, 2459051, 2459087, 2459106, 2471700, 2475668, 2475670, 2475672, 2475681, 2475690, 2475694, 2475695, 2475702, 2475704, 2528982, 2528984, 2528987, 2528988, 2529021, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 1406 | Z-0242-2013 |
| NCB® cancellous screw | REF Number: 02.02152. 085 Lot 2477869 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 2 | Z-0243-2013 |
| NCB® screw Ø 4.0 self-tapping | REF Numbers: 02.02155.026 and 02.02155.030 Lots2450611, 2475382 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 41 | Z-0244-2013 |
| NCB®-PT lateral proximal 3 hole tibial plate | REF Numbers: 02.02261.305, 02.02261.307, 02.02261.309, and 02.02261.313. Lot:2442904, 2341498, , 2402100, 2407066, 2414036, 2422428, 2426611, 2434987, 2442908, 2387467, 2387467, 2402996, 2407064, 2422433, 2450659, 2450659, 2450644, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 589 | Z-0245-2013 |
| NCB®-PH Plate | REF Numbers: 02.02262.105 and 02.02262.107. Lot 2450659, 2450644 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 95 | Z-0246-2013 |
| Sirus® intramedullary nail for tibia, cannulated Ø | REF Numbers: 02.02631.030, 02.02631.031, 02.02631.033, 02.02631.034, 02.02631.036, 02.02631.038, 02.02631.130, 02.02631.131, 02.02631.133, 02.02631.134, 02.02631.142, 02.02631.233, 02.02631.925, 02.02631.928, 02.02631.930, 02.02631.931, 02.02631.933, 02.02631.934, 02.02631.936, and 02.02631.940. Lot: 2394172, 2400103, 2400105, 2403109, 2403116, 2403125, 2403127, 2403136, 2403138, 2406268, 2406270, 2406272, 2406276, 2406278, 2406280, 2408059, 2408125, 2408131, 2408135, 2409963, 2409973, 2412348, 2414763, 2414765, 2414767, 2414773, 2414775, 2428019, 2429497, 2449749, 2449758, 2455924, 2477033, 2477059, 2490726, 2498026, | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 195 | Z-0247-2013 |
| Kopf Adapter S Sterile, Rx | REF Numbers: 01.00185.145, 146, 147, 148 2329720, 2345868, 2351558, 2351558, 2357964, 2357985, 2363710, 2365318, 2390727, 2401986, 2404475, 2420196, 2424824, 2424824, 2428509, 2449961, 2469199, 2476706, 2476706, 2476708, 2476708, 2486173, 2324764, 2335268, 2339607, 2342207, 2342207, 2342209, 2342211, 2354632, 2357988, 2365331, 2368841, 2385720, 2388044, 2396086, 2399440, 2404481, 2408183, 2414476, 2414480, 2420203, 2420203, 2424841, 2428528, 2430914, 2433313, 2455294, 2462031, 2462048, 2469203, 2469203, 2476713, 2476718, 2486178, 2486178, 2486180, 2499005, 2499005, 2509186, 2516387, 2516387, 2516389, 2314373, 2322686, 2329747, 2339609, 2339611, 2342218, 2350072, 2351571, 2351573, 2354637, 2356264, 2360204, 2430920, 2443367, 2455300, 2476723, 2482727, 2322688, 2322689, 2322689, 2335264, 2335264, 2336972, 2336972, 2399446, 2428549, 2428549, 2428549 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 2011 | Z-0248-2013 |
| MS-30 Shaft, Sterile, Rx | 30.00.49-100, 140, 160; Lots 2396807, 2390863, 2321477 | Class II | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. | 13 | Z-0249-2013 |
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