FDA Device recall Z-3197-2026
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5…
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5… 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-3197-2026 |
| 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
ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR 32X52MM UH1-52-32 UHR BIPOLAR 32X54MM UH1-54-32 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 | 69-2854 UDI-DI 07613327025491 Lots MLKY8A MLL8E1 82-2-0512 UDI-DI 04546540400611 Lot 23325151 82-2-051…69-2854 UDI-DI 07613327025491 Lots MLKY8A MLL8E1 82-2-0512 UDI-DI 04546540400611 Lot 23325151 82-2-0518 UDI-DI 04546540400635 Lot 23640051 82-2-0912 UDI-DI 04546540400758 Lot 26862851 82-3-0318 UDI-DI 04546540364319 Lot 28208551 78-5-0910 UDI-DI 07613327366006 Lots 30582401 30582601 73-2710 UDI-DI 07613327033847 Lot 14HDSA 73-2610 UDI-DI 07613327014082 Lots 193307A 193307E 73-0110 UDI-DI 07613327050288 Lot HHPW 73-0710 UDI-DI 07613327050295 Lots 8P83 DL4V 73-0910 UDI-DI 07613327050332 Lot 14NACD 3044-0026 UDI-DI 07613327033779 Lots 14SCVA 14SCVD 14SCVF 72-4-9114 UDI-DI 07613327034875 Lot 8H39KP 72-4-0324 UDI-DI 07613327034356 Lot 23505751 72-16-0512 UDI-DI 07613154020515 Lots 17376651 19093651 23125951 27835951 72-16-0518 UDI-DI 07613154020539 Lot 25621551 72-16-0912 UDI-DI 07613154020652 Lot 17879451 72-16-1112 UDI-DI 07613154020737 |
|---|
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 - 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 · 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
All Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3197-2026%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.