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PFC SIGMA Cruciate Retaining (CR) recallZ-1077-2014 · DePuy Orthopaedics, Inc. · initiated Dec 9, 2013

Class II Terminated All recalls posted in February 2014

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

Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.

FDA root cause category: Process design

What the company is doing

The recall is extended to the DePuy Distributor, Hospital, and Surgeon levels. The two affected distributors were contacted by telephone. Written communication to the two hospitals and one surgeon who received the devices will be delivered by DePuy Orthopaedics, Inc. via email or regular mail. The one affected surgeon will also be contacted by telephone by the Medical Safety Officer and a metallurgist, who will discuss the surgeon communication with the surgeon. The sales representatives aid customers in the affected device returns, as needed. The devices will be returned through the normal DePuy Returns process, to attention of Returns and marking H13-30C on the outside of the box. All (21) remaining devices have been verified as being returned and in quarantine. Effectiveness will be determined by product reconciliation, receipt of all hospital reconciliation forms, and receipt of international declaration from the International Affiliate. DePuy will follow-up with the affected hospitals until all hospital reconciliation forms are returned, and DePuy will follow-up with the International Affiliate until all international actions are complete and the international declaration is completed and return.

Recall details

Recall number
Z-1077-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 9, 2013
Posted by the FDA
Feb 24, 2014
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
2
Product code
JWH
FDA submissions
K943462
Distribution
Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.

Product description

PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.

Code information (models, lots, serial numbers)

Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)

Other devices under the same FDA submission

58 devices cleared under K943462 — 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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