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Foundation Knee System, non-porous Femur Size 8, Right recallZ-1069-03 · Encore Medical, LP · initiated Apr 24, 2003

Terminated All recalls posted in July 2003

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 Encore Medical, LP 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

Product container was labeled incorrectly indicating left femur instead of right.

FDA root cause category: Other

What the company is doing

The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.

Recall details

Recall number
Z-1069-03
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 24, 2003
Posted by the FDA
Jul 30, 2003
Recalling firm
Encore Medical, LP
Quantity
14 unimplanted units
Product code
JWH
FDA submissions
K923277
Distribution
PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia

Product description

Foundation Knee System, non-porous Femur Size 8, Right

Code information (models, lots, serial numbers)

Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201, 850611

Other devices under the same FDA submission

19 devices cleared under K923277 — 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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