smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
FDA Recall Z-2621-2023 · Posted 2023-09-20
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Recalling FirmSmith & Nephew Inc
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-08-31
Product Quantity8 units
Reason for Recall
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Firm Action
Smith & Nephew issued an Urgent Medical Device3 Recall Notice to its consignees on 08/31/2023 via letter and email. The notice explained the problem and potential risk and requested the consignee quarantine the affected product. Distributors were directed to notify their customers. Firm is seeking return of the affected product.
Root Cause
Labeling Change Control
Distribution Pattern
OH, CT, TX, NC, CA, NE, NV
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial BaseplatesSmith & Nephew, Inc. · 2023-05-04K112941LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTSSmith & Nephew, Inc. · 2011-12-20
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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