Home / Recalls / ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY / Z-1403-2025

Z-1403-2025 Class II Ongoing

Recalled by ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY — Oranmore, N/A

Recall Details

Product Type: Devices
Report Date: March 26, 2025
Initiation Date: March 3, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 90 US; 136 OUS

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.

Distribution Pattern

US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.

Code Information

Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809