Device product
smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
Z-0281-2025
Product summary
- Event
- Event 95494
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-0281-2025
Official wording
Reason: Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Code information: UDI/DI 03596010469212, Batch number 23LM02331
Distribution pattern: US Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution to country of: Canada
Derived failure modes
-
Unknown
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.