Shoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly
Zimmer Orthopedics recalls shoulder prosthesis models due to excess material in the taper that prevents proper surgical assembly. Five complaints reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with documented manufacturing defect affecting surgical implantation. Five verified complaints of excess material preventing proper device assembly. No patient injuries reported, but potential exists for surgical complications from extended operative time.
Plain-English summary
Zimmer Orthopedics Manufacturing Limited-Galway is recalling certain shoulder prosthesis models due to excess material in the taper that can prevent proper surgical assembly.
The recall affects Comprehensive Shoulder Stem, Comprehensive Micro Stem, and Comprehensive Mini Stem devices (Model Nos. 113605, 113606, 113607, 113627). Five complaints have been received where the excess material prevented surgeons from properly removing or connecting the inserter with the stem during implant placement. This can result in significant extension of surgical time while a replacement device is located.
The affected products were distributed throughout the United States and internationally to the Dominican Republic, Canada, India, Australia, Japan, EMEA countries, Korea, Taiwan, and Hong Kong. Approximately 90 units were distributed in the US and 136 units internationally.
The recalled product
- Product
- Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
- Manufacturer
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- Hazard
- manufacturing-defect
- assembly-failure
- surgical-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
Distributed nationwide across the United States.
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