Recalls / —

—#166108

Product

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

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K952830

Affected lot / code info

Lot: C2KJ24, GTIN: 10603295234135

Why it was recalled

This unit may be missing the screw/collet Assembly

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm

DePuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

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

Timeline

Recall initiated

2018-07-18

Terminated

2019-04-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #166108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.