# FDA recall Z-3203-2026

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

## Product

SCORPIO RECESSED METAL BACKED PATELLA	  	3045-0026  	3045-0028  	3045-0030  	3045-0032    	  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-3203-2026
- **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-3203-2026

## Citation

> MORVS. FDA recall Z-3203-2026. Retrieved 2026-10-16 from https://api.morvs.ai/recall/Z-3203-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*