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Terminated

LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.

FDA Recall Z-0816-2016 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2016-01-18
Date Terminated2016-05-25
Product Quantity8 units

Reason for Recall

The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.

Firm Action

The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.

Root Cause

Packaging change control

Distribution Pattern

Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043440SMITH & NEPHEW, INC. REVISION KNEE SYSTEMSmith & Nephew, Inc. · 2005-02-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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