Official recall record
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 1
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-03-03
- Country of alert
- Ireland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00887868267550
- Brand on record
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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