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Size 6 right Foundation Total Knee System (Catalog… recallZ-0331-06 · Encore Medical, Lp · initiated Nov 3, 2005

Terminated All recalls posted in December 2005

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

The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

FDA root cause category: Other

What the company is doing

Firm initiated recall on 11/03/05 via letter to all consignees.

Recall details

Recall number
Z-0331-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 3, 2005
Posted by the FDA
Dec 29, 2005
Recalling firm
Encore Medical, Lp
Quantity
16 units.
Product code
JWH
FDA submissions
K923277
Distribution
Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.

Product description

Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.

Code information (models, lots, serial numbers)

Lot #426142 and #426132.

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 33991).

Sources and updates

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