Data Foundry

Medical device recalls 2025

Z1 Femoral Hip System — Class II medical device recall Z-1329-2025

Ongoing recall by Zimmer, Inc., reported 2025-03-19, distributed nationwide. There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Recall numberZ-1329-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmZimmer, Inc., Warsaw, IN, United States
Recall initiated2025-02-12
Classified2025-03-13
Reported by FDA2025-03-19
DistributedNationwide (US)
Quantity35 units
UPC / GTIN / UDI-DI00887868577888
Lot numbers102646, 102777, 102778, 104095, 104324, 105277

Product

Z1 Femoral Hip System, Product Number 611777612

Reason for recall

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1329-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.