# FDA recall Z-3201-2026

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

## Product

ACETABULAR CUP UHMWPE	  	61-3258  	  ALL POLY CONSTRAINED INSERT 44MM	  	69-2244  	  ALL POLY CONSTRAINED INSERT 46MM	  	69-2246  	  ALL POLY CONSTRAINED INSERT 48MM	  	69-2248  	  ALL POLY CONSTRAINED INSERT 50MM	  	69-2850  	  ALL POLY CONSTRAINED INSERT 52MM	  	69-2852  	  CONSTRAINED ACETABULAR INSERTS 22MM 50MM	  	2099-2250  	  CONSTRAINED ACETABULAR INSERTS 22MM 52MM	  	2099-2252  	  CONSTRAINED ACETABULAR INSERTS 22MM 56MM	  	2099-2256  	  CONSTRAINED ACETABULAR INSERTS 28MM 61MM	  	2099-2861  	  EIUS UNI TIB SMALL RM/LL 9MM	  	6636-0-419  	  PCA CONST LINER 32MM NEUTRAL C - SHELL	  	6299-N-332  	  SYS 12 CONST LINER 32ID 10 DEG P6 +4MM	  	6302-H-632  	  TRIDENT 0 DEG CONSTRAINED INSERT 22D	  	690-00-22D  	  TRIDENT 0 DEG CONSTRAINED INSERT 22E	  	690-00-22E  	  TRIDENT 0 DEG CONSTRAINED INSERT 28F	  	690-00-28F  	  TRIDENT 0 DEG CONSTRAINED INSERT 28G	  	690-00-28G  	  TRIDENT 0 DEG CONSTRAINED INSERT 32I	  	690-00-32I    TRIDENT 0¿ POLY INSERT 28mm ID	  	620-00-28D  	  TRIDENT CONSTR ACET INSERT	  	690-10-28K    TRIDENT CONSTRAINED INSERT	  	690-10-22E  	690-10-22F  	690-10-28G  	690-10-28H  	690-10-28I    	  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-3201-2026
- **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-3201-2026

## Citation

> MORVS. FDA recall Z-3201-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-3201-2026. Source: US FDA. Licensed CC0.

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