Scorpio Total Knee Cruciate Retraining Femoral Component recallZ-1381-2008 · Stryker Howmedica Osteonics Corp. · initiated Feb 8, 2005
Terminated All recalls posted in July 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.
FDA root cause category: Labeling mix-ups
What the company is doing
Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Recall details
- Recall number
- Z-1381-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 8, 2005
- Posted by the FDA
- Jul 16, 2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 7 units
- Product code
- JWH
- FDA submissions
- K974556
- Distribution
- Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
Product description
Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
Code information (models, lots, serial numbers)
Lot Number: K04W966.
Other devices under the same FDA submission
4 devices cleared under K974556 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Scorpio 70-3011LHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Scorpio 70-3011RHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Scorpio 70-4107RHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Scorpio 70-4113RHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 47219).
- Z-1382-2008 · TerminatedScorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; St…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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