ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY: Medical Device Recall in 2025 - (Recall #: Z-1403-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

Product Classification:

Class II

Date Initiated: March 3, 2025

Date Posted: March 26, 2025

Recall Number: Z-1403-2025

Event ID: 96398

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.

Status: Ongoing

Product Quantity: 90 US; 136 OUS

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated