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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Device Recall Strykersee related information
Date Initiated by FirmJuly 30, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3199-2026
Recall Event ID 99558
510(K)NumberK261624 
Product Classification Prosthesis, hip, hemi-, femoral, metal - Product Code KWL
ProductABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 C-M064-4-300 TRIATHLON NO. 9 TIBIAL INSERT 11MM C-M067-5-003 TRIATHLON NO. 9 TIBIAL INSERT 9MM C-M067-5-002 TRIDENT ALL POLY CUP 44 X 66MM C-M066-0-901 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID UH1 C-M104-2-002 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID UH1 C-M104-2-003 UHR BIPOLAR 22X38MM UH1-38-22 UHR BIPOLAR 22X40MM UH1-40-22 UHR BIPOLAR 22X41MM UH1-41-22 UHR BIPOLAR 22X42MM UH1-42-22 UHR BIPOLAR 22X43MM UH1-43-22 UHR BIPOLAR 22X45MM UH1-45-22 UHR BIPOLAR 26X41mm UH1-41-26 UHR BIPOLAR 26X42mm UH1-42-26 UHR BIPOLAR 26X43mm UH1-43-26 UHR BIPOLAR 26X44mm UH1-44-26 UHR BIPOLAR 26X45mm UH1-45-26 UHR BIPOLAR 26X46mm UH1-46-26 UHR BIPOLAR 26X47mm UH1-47-26 UHR BIPOLAR 26X48mm UH1-48-26 UHR BIPOLAR 28X42mm UH1-42-28 UHR BIPOLAR 28X44mm UH1-44-28 UHR BIPOLAR 28X45mm UH1-45-28 UHR BIPOLAR 28X46mm UH1-46-28 UHR BIPOLAR 28X47mm UH1-47-28 UHR BIPOLAR 28X48mm UH1-48-28 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Code Information C-M079-2-801 No UDI Lot G3264034 C-M071-6-700 No UDI Lot G3043883 C-M071-8-400 No UDI Lot G3043878 C-M110-1-201 UDI-DI 07613327504811 Lot 573P37 C-MM100253-02 No UDI Lot N8873H C-M066-3-000 No UDI Lot RX06630A C-M082-7-303 No UDI Lot L6237 C-M107-5-301 No UDI Lot 193607 C-MM100616-02 No UDI Lot 195261 C-MM100616-03 No UDI Lot 195262 C-MM100616-01 No UDI Lot 195260 C-MM100520-03 No UDI Lot 195081 C-MM100520-04 No UDI Lot 195082 C-MM100520-02 No UDI Lot 195080 C-MM100411-03 No UDI Lot 194962 C-MM100411-04 No UDI Lot 194963 C-MM100411-02 No UDI Lot 194961 C-MM100507-04 No UDI Lot LNH795 C-MM100507-06 No UDI Lot LNH797 C-M071-6-601 No UDI Lot G3055684 C-M113-5-603 No UDI Lot 194594 C-M067-3-103 No UDI Lot MHP0AX C-M107-7-801 No UDI Lot 193479 C-M064-4-300 No UDI Lot RX06443A C-M067-5-003 No UDI Lot RX06750D C-M067-5-002 No UDI Lot RX06750C C-M066-0-901 No UDI Lot RX06609B C-M104-2-002 No UDI Lot 192371 C-M104-2-003 No UDI Lot 192370 UH1-38-22 UDI-DI 07613327016789 Lots 2A01TA 430715 49510K 7E5X23 852J98 D23664 NE659N UH1-40-22 UDI-DI 07613327016796 Lots 128LXW 16182H 1J5955 1T8203 2137N4 2541YM 2Y52Y2 4E19VD 4K7XYL 577M4L 5D3AVR 746AV4 7V8J0V 828TAR 875M72 8V63LX 9A3W5N A91P07 DL4D38 LW709R RA6A1H VT4K59 X95RTV UH1-41-22 UDI-DI 07613327016819 Lots 343653 4P1TR7 521MLK 7Y8HEA 975A6Y AR0KX5 E788E6 KL1YTE KN0086 P043ME PL4L5M UH1-42-22 UDI-DI 07613327016833 Lots 1R2VD1 2E84HD 2X333W 4L5YMY 6J2W2P 7238R2 7883W1 7H2L8M 8K315D AK2P91 ET3HWR L16J85 L93PY2 ME1485 MY1N20 P987D0 R92PDW TM0KR0 X884ET XD3961 YK39TT UH1-43-22 UDI-DI 07613327016840 Lots 11138V 23005R 481KR9 516JLV 761T5M 9W3NWV DA0W51 EK6069 KP0AAD MD1Y5V NT68KL RT8N8H RY828P UH1-45-22 UDI-DI 07613327016901 Lots 8Y0KWH HR869M R7168K WR4MT4 UH1-41-26 UDI-DI 07613327016802 Lots 157V1T 1D33YX 1K1E6M 1R5LWT 218RED 254MT3 287D4A 2K7HXW 2X5MTA 3J1A39 3K3P0T 473K4V 5A1T5N 5D6KJ5 5V7H82 6J8XKT 6W1MKA 8R29TH 9T7N8Y AL5K8M AW02V8 DT8JEW H04PHL JR6R9L LN70PY MA6M6E PE7T6P PY8PLH RY49EW T1497X V70PNP VJ6WXM X82M1D UH1-42-26 UDI-DI 07613327016826 Lots 186JE6 5Y1RL7 618AMX 7J0XET MLKT5A MLL022 MLL05K R50NW2 UH1-43-26 UDI-DI 07613327016864 Lots 192J0R 1D45L5 1H5V53 2P2A99 2V6D0R 3248V2 334851 386P0V 3N33VT 402RP3 4644KD 4J5Y6H 4L3JPP 5H1A45 5Y2422 626J60 6E33NR 6J30X2 6M2KK8 6V092N 761EJP 7820L1 791NPH 7D0H4K 7K28Y8 7K63EE 7N7WX1 817AJJ 8J6TAL 8L6R73 8T3XDK 983JDR 998H5N 9E631T A93KWD AY40L3 DJ105H E521L6 EX5DA9 HW7XYK J94M7R JT565R JX0L8R K939KP KA30HV KE5770 KP1Y0E KV3L3H MD76WR MJ1DY9 MK2MN3 MLL54K MLL65N MLLV64 MR6D42 MW2J8W N314DK NP48X0 P147V0 P502R8 P92DV1 RL1TL1 RN8NM1 T66JK4 TA20N9 TT3EJR TV197Y TY7YV5 V68NXH V91EK1 VW74NJ VX5T02 VY0525 WA0VRE WT7P1A X48P1Y Y63LYJ Y648WL YE3W2X YJ6PHM YL3HVY YL6L7K YX8NTJ UH1-44-26 UDI-DI 07613327016888 Lots 336652 581XTY 5H1YRH 640Y4R 7Y7H14 9J7T4L A881HX JN7TXM KT4P91 LJ44JX M52APN MLL2PT MLL5X1 MLLD4R MLLPK1 MLLV2Y NR773K NV0NVX PD7P36 R74D1D T31P16 VK7JL5 W91ENE XD45XY XN8EWL Y385N4 YN1AJN UH1-45-26 UDI-DI 07613327016925 Lots 056MNE 059MNE 188AWK 243WTY 352XY0 442K1P 8L58NK AJ0H2R AN15H5 HX6PAR HY2V81 L50T23 MLL0AE MLL5J4 MLL9TV MLLKNT N88PKJ P31A9Y RJ8JPR UH1-46-26 UDI-DI 07613327016949 Lots 1839Y2 1M2AX3 1P2E82 1V5AN9 226AWD 232X83 2465J7 2K0P93 2R3XD6 3614YL 394D8M 3P7091 4V2PVP 5389M0 5N2N75 9X7YK5 A35V7K DW3J8W DY85VA E242NY H07J22 JV88X1 L04PPV LY44K5 MLL50M MLL789 MLLA53 NE45DD V94NTT YY5N98 UH1-47-26 UDI-DI 07613327016987 Lots 1Y2K34 21197T 3E0A48 4E7MKW 7K1VLW A58HN9 J38RE2 J60A4E LT43X0 M15HKN MK442Y MLL2LR MLL52N MLLRMW MLLVRW MLLWVH XD724J UH1-48-26 UDI-DI 07613327017007 Lots 1J8K9L 2Y6JK3 350D6V 3845V3 3D6216 44827N 580Y68 726W7P 7L7TPP 8E7A1J 9V8P94 9Y6HML H88E74 K54MN4 L783M7 MLL3E9 MLL52W MP56YN N00HDA N26TW7 TR4TT5 W016KY XJ48DN YA4YPN UH1-42-28 UDI-DI 07613327016857 Lots 1R5MDV 275NEA 2V6KMY 4215LV MLKEHT MLLJ5X MLLJK9 MLLV75 UH1-44-28 UDI-DI 07613327016895 Lots 106X12 121A72 123MX4 138KNV 1401YE 1429X2 154N34 1740KE 1830AR 186WEL 1D8LYA 1E4HK2 1E6W32 1E7RRN 1H1P69 1K10H5 1K58A6 1K63LK 1M1W89 1M6JWR 1N6VPP 1R8333 1V4LXR 1X8R7X 1Y2V83 1Y7DPY 201MY5 2116XX 2286V1 25090N 251WMR 2550NN 261Y8Y 287N2R 2D4N58 2X5T7Y 335351 335EXD 391JXR 3K6YR2 444636 4E45R8 4K15YY 4L17DL 4L29A4 4M7J5A 4N2091 4P3L83 4T85VA 4W227H 518WTR 521K2M 5246AR 5325D6 534JYN 555249 558TVA 581YM9 5D1Y5V 5H0EXH 5K0AMY 5P0H6D 5R3H24 5V2RJ0 600TDM 623LA2 6370A6 681Y0M 6885NJ 693MRX 698Y2M 6L4LT7 6N4J52 6T3JAY 6V19AE 6V6DW2 6W0A59 7307MN 758K2A 768V6X 7D5MN2 7L230N 7M6YVP 7X2PH3 7X7XM0 8125RN 867YNX 886V7A 8E6V9P 8M114H 8M4W64 8R438X 8X4PRJ 971KAN 987WJ0 9H673H 9K656K 9V0L0L A56J67 A85T4Y A86V5E AA7VL4 AM3PPW AW6JML DD37HD DH5N6T DL5E4X DR69YE E47VAT EA6WY1 EK5N6A EK8KDD EN17M3 ER2VAV HW14NW J477D9 J63M24 J644K6 JE7K73 JT2PYD K47JDR KD174L L548RP LE83EE LH10XA LM74JP LR3KT5 LV0PP9 M45LKM MLKMWA MLL0X7 MLL3T3 MLL3X8 MLL3YN MLL5V9 MLL6E1 MLL70V MLLA90 MLLDXM MLLEEY MLLLKA MLLNDM MLLR0R MLLY2V MT2YK4 MT56MX N082LN N35W9W N4476X N60KXY N780A7 N80J7M NR5X7N NW7H6M PN3K4T PV87N1 R20NVJ RM8HJJ RY4JDM T6297W T73HN0 TP366X V281XV V64XWE V95MVD VA7769 VL3RJJ VP8E88 W33XH8 W969RX WD03AK WJ4YYD WK2AHL WW6MVP X16M08 XM319D XN437D Y703W8 YJ012E YV08TH YY4TKX UH1-45-28 UDI-DI 07613327016918 Lots 1A3013 360RPN 486EJ1 4N85AM D6348Y EY829J MLL1V3 MLL210 MLL24J MLL44A MLL5RM MLL94Y MLLDXY MLLJRN MLLVWK MLLW3M MLLY7V X43WJN UH1-46-28 UDI-DI 07613327016956 Lots 1804DD 29772K 2E5PX4 3402DJ 3P0NDP 4H0W7N 4J5R3M 4K0NDA 5818XA 5R5H8L 6N77PT 6T493L 7K0L36 7L1KRT 8015WY 802XY1 8P7D00 905HH2 AD0E56 D3227P E83XET EV4W50 HT21XV JP0TKR L00E8N M25670 MLL0Y0 MLL1W9 MLL46R MLL499 MLL602 MLL8Y7 MLLAYE MLLDY9 MLLJWN MLLK40 MLLKEH MLLNE3 MLLRL2 MLLV8T MLLVTD MLLXV3 MR613J NT30DY P72N17 VE411K WH517T XH01PP Y66HVE YE5XLP UH1-47-28 UDI-DI 07613327016970 Lots 2821VP 2N68HT 3682T6 3M0Y7N 4E58YD 661DW6 8K6225 8M60J8 9D22DE 9Y0X3H A68HK5 AL4LYE J60DLA KM65D9 LJ3RRT MLL8V0 MLL984 MLLH9P MLLLLD MLLND6 PV1K03 PW100N TD5KRD WX0R02 UH1-48-28 UDI-DI 07613327017014 Lots 1831VA 1M4NYV 1T0L93 1W0E1J 254N4A 294M71 2A2RJ0 2T45AP 3K8VM4 3T6PD5 3Y8DJX 437ANA 448V4T 4623VM 484LE9 4X0M53 5D50WT 5L074T 5T0PX8 6E2MX7 6K5Y7V 6L43JP 7A1HVY 8J8DDN 975VXR 9786P2 9D6M48 9M6KHT 9T2991 9X5MJ3 A228M1 A54PLW A77V1M AV5ANE AX18R8 DK0M6J DY3LR8 E600KE EY5P9V H558EP H63W11 HP74LE J72DLP J76YJ6 JK7JY4 JL1T01 K47WL6 K728DH KT3K27 L35VMM M15D88 ML731E MLL18D MLL562 MLL6MH MLL74R MLLM4T MLLMWV MLLNTV MLLPV9 MLLV38 MLLX14
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactEvelyn Ryan
201-831-5000
Manufacturer Reason
for Recall		Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
FDA Determined
Cause 2		Process change control
ActionFirm began notifying customers on July 30, 2026, via FedEx 2-day air. Customers were instructed to quarantine and discontinue use of the affected product. Affected product should be returned to the firm.
Quantity in Commerce12,156 US
DistributionWorldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KWL
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