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Terminated

Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to replace the articulating surface of the distal femur.

FDA Recall Z-0795-2010 · Posted 2010-02-19

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2007-07-30
Date Terminated2010-02-19
Product Quantity7

Reason for Recall

Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.

Firm Action

Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution -- United States and France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMOsteonics Corp. · 1996-08-14

Official Source

View FDA Recall →

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

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