Comprehensive Shoulder Stem recall
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607…
Why was Comprehensive Shoulder Stem recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607…
- Recalling firm
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- Quantity
- 90 US; 136 OUS
- Distribution
- US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)