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Scorpio PS Femoral Waffle (No post) and LFIT recallZ-0795-2010 · Stryker Howmedica Osteonics Corp. · initiated Jul 30, 2007

Terminated All recalls posted in February 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

Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.

FDA root cause category: Labeling mix-ups

What the company is doing

Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825.

Recall details

Recall number
Z-0795-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 30, 2007
Posted by the FDA
Feb 19, 2010
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
7
Product code
JWH
FDA submissions
K962152
Distribution
Worldwide Distribution -- United States and France.

Product description

Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to replace the articulating surface of the distal femur.

Code information (models, lots, serial numbers)

Scorpio (no post) with LFIT: Product code 72-4107-L; Lot code: JKWMHD;

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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