Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1403-2025 — Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

U.S. FDA — Device Enforcement · Ireland · 2025-03-03 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1403-2025
Date of alert
2025-03-03
Country / jurisdiction
Ireland
Risk level
Class II
Risk type
recall
Brand
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00887868267550
Reported risk: Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.