Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Reported: March 26, 2025 Initiated: March 3, 2025 #Z-1403-2025
Product Description
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Reason for Recall
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.
Details
- Recalling Firm
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- Units Affected
- 90 US; 136 OUS
- Distribution
- US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
- Location
- Oranmore, N/A
Frequently Asked Questions
What product was recalled? ▼
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627. Recalled by ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY. Units affected: 90 US; 136 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1403-2025.
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