Device product
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
Z-1036-2023
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 91423
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1036-2023
Official wording
Reason: Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement
Code information: UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620
Distribution pattern: US Nationwide distribution in the states of CA, KY, FL.
Derived failure modes
-
Unknown
Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement