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Terminated

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

FDA Recall Z-2949-2018 · Posted None

Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2018-07-18
Date Terminated2019-04-17
Product Quantity1

Reason for Recall

This unit may be missing the screw/collet Assembly

Firm Action

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.

Root Cause

Employee error

Distribution Pattern

The devices were not distributed in the United States. The devices were distributed to the following foreign countries: Great Britain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952830DARWIN KNEE SYSTEM (TC3)Johnson & Johnson Professionals, Inc. · 1996-01-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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