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Foundation Knee System, Tibia-Nonporous, Size 6, Right… recallZ-1010-04 · Encore Medical, LP · initiated May 10, 2004

Terminated All recalls posted in July 2004

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

Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE

FDA root cause category: Other

What the company is doing

The firm sent recall letters to all consignees on May 10, 2004 requesting return of the product.

Recall details

Recall number
Z-1010-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 10, 2004
Posted by the FDA
Jul 20, 2004
Recalling firm
Encore Medical, LP
Quantity
15
Product code
JWH
FDA submissions
K923277
Distribution
Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.

Product description

Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758

Code information (models, lots, serial numbers)

Catalog number 324-01-106, Lot number 991151

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 29130).

Sources and updates

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