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Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right recallZ-1141-2010 · Stryker Howmedica Osteonics Corp. · initiated Aug 20, 2007

Terminated All recalls posted in March 2010

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

A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.

FDA root cause category: Process design

What the company is doing

Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.

Recall details

Recall number
Z-1141-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 20, 2007
Posted by the FDA
Mar 16, 2010
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
4 units
Product code
JWH
FDA submissions
K030978
Distribution
Product went to 2 US Stryker branches.

Product description

Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

Code information (models, lots, serial numbers)

Product Code: 814407R; Lot Code: L65MKD

Other devices under the same FDA submission

11 devices cleared under K030978 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page