Device product
Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
Z-2300-2020
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 85658
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38
- Official record key
device-enforcement:Z-2300-2020
Official wording
Reason: The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
Code information: Lots 814100, 570640, 728890, 977300
Distribution pattern: US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.
Derived failure modes
-
Unknown
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.