Reported Sep 23, 2026 · Ongoing · Updated Sep 29, 2026
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…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- 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)
- Lot codes and dates
- 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 LotsUDI-DI 07613327138214 Lots
AFZT00UAFZT00ZP2N04BP3K57P3K57BP3K57FPYE43BPZA70FPZA70U5361-6105
UDI-DI 07613327138207 LotsAF2S09UAF2S09ZP1H41P4T02P4T02X1P4T02X2P4T02X3P4T02X4P4T02X5P4T02X65361-6107
UDI-DI 07613327138153 Lots AF3E02I AF3E02S AF3E02Z P1H39Q 5361-6211 UDI-DI 07613327138283 LotsAF3E00AF3E00BAF3E00FAF3E00GAF3E00QAF3E00SP4A238P4A238X1P4A238X2P4A238X3P4A238X4P4A238X5P4A238X6P4A238X7P4A238X8P4L09P4L09X1P4L09X10P4L09X2P4L09X3P4L09X4P4L09X5P4L09X6P4L09X7P4L09X8P4L09X9P4N06P4N06X1P4N06X2P4N06X3P4N06X4P4N06X5P4N06X6P4N06X7P4T03P4T03X1P4T03X2P4T03X3P4T03X4P4T03X5P4T03X6P4T03X7P4T03X8P4V01P4V01X1P4V01X2P4V01X3P4V01X4P4V01X5P4V01X6P4V01X7P4V01X85361-6109
UDI-DI 07613327138177 Lots 1NMMPE 1NNMPE P3K58 P3K58B P3K58F 5361-6207 UDI-DI 07613327138269 LotsAFZS09FAFZS09GAFZS09SP2N08PYC30X1PYW24X1PZKDHX15361-6205
UDI-DI 07613327138238 Lots AF2K03Z AFZS10S AFZS10UAF2S10BAF2S10FAF2S10GP4A241P4A241X1P4A241X2P4A241X3P4V03P4V03X1P4V03X2P4V03X3P4V03X4P4V03X5PZKDFX15361-6209
- 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
- Amount recalled
- 12,156 US
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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