Comprehensive Shoulder Stem (Zimmer) – Surgical Insertion Problem (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Brand
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland
Lot Codes / Batch Numbers
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
Products Sold
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
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland is recalling Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder due to Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026