Recall Z-1403-2025— ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Class II · Ongoing
Class II FDA medical device recall by ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY, initiated 2025-03-03. It names one FDA 510(k) clearance: K193038. Product: Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627. Reason: 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..
- Recalling firm
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-03
- Firm location
- Oranmore, N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.