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P.F.C. Knee System 7 recallZ-1369-04 · Depuy Orthopaedics, Inc. · initiated Dec 22, 2003

Terminated All recalls posted in August 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 Depuy Orthopaedics, Inc. 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 collar was incorrectly etched for the R (right) and L (Left) orientation

FDA root cause category: Other

What the company is doing

Depuy notified distributors at the various territories via verbal contact on 12/23/2003

Recall details

Recall number
Z-1369-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 22, 2003
Posted by the FDA
Aug 24, 2004
Recalling firm
Depuy Orthopaedics, Inc.
Quantity
1 unit
Product code
JWH
FDA submissions
K952830
Distribution
NY

Product description

P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703

Code information (models, lots, serial numbers)

Lot Number: 226436R

Other devices under the same FDA submission

76 devices cleared under K952830 — 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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