Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No
Summary
The FDA issued a Class II for Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; by ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY. Reason: Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining .
Details
Source
Device Recall
External ID
Z-1403-2025
Action Date
2025-03-26
Status
Ongoing
Category
device
Product Description
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Lot/Code Info: 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
Quantity Affected: 90 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.
Distribution
US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-03
Company
Oranmore, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY have FDA actions?
This is the only FDA action we have on record for ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1403-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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