Scorpio Total Knee Cruciate Retaining Femoral Component… recallZ-0058-06 · Stryker Howmedica Osteonics Corp. · initiated Aug 11, 2005
Terminated All recalls posted in October 2005
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
The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
FDA root cause category: Other
What the company is doing
The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.
Recall details
- Recall number
- Z-0058-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 11, 2005
- Posted by the FDA
- Oct 15, 2005
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 8 units
- Product code
- JWH
- FDA submissions
- K974556
- Distribution
- The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.
Product description
Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
Code information (models, lots, serial numbers)
Catalog No: 70-4107L Lot Code: K04W537
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 33035).
- Z-0059-06 · TerminatedScorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
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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