LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Knee prosthesis component.
FDA Recall Z-1951-2021 · Posted None
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Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2021-05-19
Date Terminated2023-04-14
Product Quantity5 units
Reason for Recall
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Firm Action
On 5/19/2021, the firm issued letters dated 5/19/2021 via overnight mail or via email explaining the issue, potential risk of use of the product, and required actions, which are listed on the response form.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of FL, NE, NY, and TX. There was no foreign/government/military distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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