FDA recall Z-1403-2025

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-03-03
Report date: 2025-03-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Oranmore, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2025