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U.S. Department of Health and Human Services

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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® 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® 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
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
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® 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
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® 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® 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
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
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
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
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" 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 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
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" 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 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" 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
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 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
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
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
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
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
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® 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
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