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Terminated

Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.

FDA Recall Z-1382-2008 · Posted 2008-07-16

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-02-08
Date Terminated2008-07-16
Product Quantity5 units

Reason for Recall

Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.

Firm Action

Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.

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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