FDA Device recall Z-3200-2026
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 SELF-PRESSURIZING GL…
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of 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 GL… by Howmedica Osteonics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3200-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-30 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | 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-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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Howmedica Osteonics
- BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured fro…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufa…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics - SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-442…
FDA Device · Class II · 2026-09-23 · Howmedica Osteonics
All Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3200-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.