Recall Z-3199-2026
Howmedica Osteonics Corp. · initiated July 30, 2026
Product
ABG 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)
Codes / lots: 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…
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: Process change control
Action taken
Firm 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.
Details
- Recall number
- Z-3199-2026
- Initiated
- July 30, 2026
- Posted by FDA
- September 16, 2026
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Quantity
- 12,156 US
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Recalling firm
- Howmedica Osteonics Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3195-2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3196-2026 | OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3197-2026 | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3198-2026 | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3200-2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3201-2026 | ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3202-2026 | BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3203-2026 | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3204-2026 | TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3205-2026 | SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |
| Z-3206-2026 | SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | 07/30/2026Open, Classified |