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Scorpio Total Knee Posteriorly Stabilized Femoral… recallZ-1814-2008 · Stryker Howmedica Osteonics Corp. · initiated Nov 8, 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

Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.

FDA root cause category: Employee error

What the company is doing

Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.

Recall details

Recall number
Z-1814-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 8, 2005
Posted by the FDA
Sep 11, 2008
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
8 units
Product code
KWY
FDA submissions
K962152
Distribution
Worldwide Distribution

Product description

Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.

Code information (models, lots, serial numbers)

Catalog No: 71-4107R, Lot Code: K05L310; Catalog No: 71-4506L, Lot Code K05L224

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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