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Recall Observatory FDA recall evidence

Device product

smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic

Z-0281-2025

October 02, 2024

Class II

Product summary

Firm
Smith & Nephew Inc
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

    reason.no_named_rule · v1.0.0

    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.