# FDA recall Z-3197-2026

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2026-07-30.

## 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 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

Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.

## Key facts

- **Recall number:** Z-3197-2026
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-30
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3197-2026

## Citation

> MORVS. FDA recall Z-3197-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-3197-2026. Source: US FDA. Licensed CC0.

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