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Osteonics Scorpio Total Knee recallZ-2079-2008 · Stryker Howmedica Osteonics Corp. · initiated Mar 17, 2005

Terminated All recalls posted in September 2008

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.

FDA root cause category: Process control

What the company is doing

The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005

Recall details

Recall number
Z-2079-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 17, 2005
Posted by the FDA
Sep 16, 2008
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
1 unit
Product code
JWH
FDA submissions
K962152
Distribution
The one unit was distributed to an International Stryker branch.

Product description

Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.

Code information (models, lots, serial numbers)

Catalog No. 711-4513L; Lot Code: K04S174

Other devices under the same FDA submission

8 devices cleared under K962152 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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