ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY recalls Comprehensive Shoulder Stem

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.

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

On March 3, 2025, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were informed of the excess metal on the inner taper of the stem due to a chipped manufacturing tool. Customers were asked to notify all affected persons and assist their Zimmer Biomet sales representative in quarantining all affected product on hand. The products will be removed from your facility.

• FDA enforcement recordOfficial FDA database entry for Z-1403-2025
• FDA 510(k) clearance · K193038The device's official FDA premarket clearance record
• FDA device classification · MBFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3670The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAYSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.