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Open, Classified

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

FDA Recall Z-1403-2025 · Posted 2025-03-20

Recalling FirmZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Recall StatusOpen, Classified
Product CodeMBF
Date Initiated2025-03-03
Product Quantity90 US; 136 OUS

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.

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp · 2020-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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