DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-...
FDA Device Recall #Z-3200-2026 - Class II, July 30, 2026
Recall Summary
| Recall Number | Z-3200-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 30, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Howmedica Osteonics Corp. |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 12,156 US |
Product Description
DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER - GLENOID #7 5361-6107 SHOULDER - GLENOID #9 5361-6109 SHOULDER - KEELED GLENOID #11 5361-6211 SHOULDER - KEELED GLENOID #5 5361-6205 SHOULDER - KEELED GLENOID #7 5361-6207 SHOULDER - KEELED GLENOID #9 5361-6209 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Lot / Code Information
C-M064-1-300 No UDI Lot RX06413A C-M062-6-800 No UDI Lot RX06268A C-M062-7-500 No UDI Lot RX06275A C-M063-2-600 No UDI Lot RX06326A C-M063-5-000 No UDI Lots RX06350A RX06350AA 5361-6111 UDI-DI 07613327138191 Lots AFZT00U AFZT00Z P2N04B P3K57 P3K57B P3K57F PYE43B PZA70F PZA70U 5361-6105 UDI-DI 07613327138214 Lots AF2S09U AF2S09Z P1H41 P4T02 P4T02X1 P4T02X2 P4T02X3 P4T02X4 P4T02X5 P4T02X6 5361-6107 UDI-DI 07613327138207 Lots AF3E00 AF3E00B AF3E00F AF3E00G AF3E00Q AF3E00S P4A238 P4A238X1 P4A238X2 P4A238X3 P4A238X4 P4A238X5 P4A238X6 P4A238X7 P4A238X8 P4L09 P4L09X1 P4L09X10 P4L09X2 P4L09X3 P4L09X4 P4L09X5 P4L09X6 P4L09X7 P4L09X8 P4L09X9 P4N06 P4N06X1 P4N06X2 P4N06X3 P4N06X4 P4N06X5 P4N06X6 P4N06X7 P4T03 P4T03X1 P4T03X2 P4T03X3 P4T03X4 P4T03X5 P4T03X6 P4T03X7 P4T03X8 P4V01 P4V01X1 P4V01X2 P4V01X3 P4V01X4 P4V01X5 P4V01X6 P4V01X7 P4V01X8 5361-6109 UDI-DI 07613327138153 Lots AF3E02I AF3E02S AF3E02Z P1H39Q 5361-6211 UDI-DI 07613327138283 Lots AFZS09F AFZS09G AFZS09S P2N08 PYC30X1 PYW24X1 PZKDHX1 5361-6205 UDI-DI 07613327138177 Lots 1NMMPE 1NNMPE P3K58 P3K58B P3K58F 5361-6207 UDI-DI 07613327138269 Lots AF2S10B AF2S10F AF2S10G P4A241 P4A241X1 P4A241X2 P4A241X3 P4V03 P4V03X1 P4V03X2 P4V03X3 P4V03X4 P4V03X5 PZKDFX1 5361-6209 UDI-DI 07613327138238 Lots AF2K03Z AFZS10S AFZS10U
Other Recalls from Howmedica Osteonics Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0166-2027 | Class II | Triathlon Hinge Femoral Prep Tray. Catalog Numb... | Sep 16, 2026 |
| Z-0165-2027 | Class II | TS Femoral Prep Tray, Triathlon. Catalog Number... | Sep 16, 2026 |
| Z-0164-2027 | Class II | TS Universal Baseplate Finishing Tray, Triathlo... | Sep 16, 2026 |
| Z-0167-2027 | Class II | TS Misc. Instruments Tray, Triathlon. Catalog N... | Sep 16, 2026 |
| Z-3196-2026 | Class II | OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Cat... | Jul 30, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.