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P.F.C. SIGMA recallZ-2949-2018 · DePuy Orthopaedics, Inc. · initiated Jul 18, 2018

Terminated

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

This unit may be missing the screw/collet Assembly

FDA root cause category: Employee error

What the company is doing

The notification letter distributed in July 2018 instructed the customer to perform the following actions: " Please cease using the affected device immediately. " Medical facility to return affected implant immediately to their Sales Consultant. " Review this notice and complete the Acknowledgement section (Attachment A) to signify that your facility has been informed of this recall. Return the completed Acknowledgement to your Sales Consultant within five (5) working days of this notice. " Retain a copy of the completed Acknowledgement Form in your files along with this notice. " Notify surgeons at your facility by providing them with a copy of this notice to ensure surgeons are aware of this recall. " Share this notice with others in your facility who need to be informed.

Recall details

Recall number
Z-2949-2018
Status
Terminated
Initiated by the company
Jul 18, 2018
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
1
Product code
JWH
FDA submissions
K952830
Distribution
The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.

Product description

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

Code information (models, lots, serial numbers)

Lot: C2KJ24, GTIN: 10603295234135

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

76 devices cleared under K952830 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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