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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive Shoulder

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 Class 2 Device Recall Comprehensive Shouldersee related information
Date Initiated by FirmMarch 03, 2025
Date PostedMarch 20, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1403-2025
Recall Event ID 96398
510(K)NumberK193038 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented - Product Code MBF
ProductComprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
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
FEI Number 3012319330
Recalling Firm/
Manufacturer		 ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Deerpark Industrial Estate
Oranmore Ireland
For Additional Information Contact411 Technical Services
574-3713071
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
Quantity in Commerce90 US; 136 OUS
DistributionUS distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MBF
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