Date Initiated by Firm | July 18, 2018 |
Create Date | August 29, 2018 |
Recall Status1 |
Terminated 3 on April 17, 2019 |
Recall Number | Z-2949-2018 |
Recall Event ID |
80666 |
510(K)Number | K952830 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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Product | P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 |
Code Information |
Lot: C2KJ24, GTIN: 10603295234135 |
Recalling Firm/ Manufacturer |
DePuy Orthopaedics, Inc. 700 Orthopaedic Dr Warsaw IN 46582-3994
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For Additional Information Contact | Mindy K. Tinsley 574-372-7136 |
Manufacturer Reason for Recall | This unit may be missing the screw/collet Assembly |
FDA Determined Cause 2 | Employee error |
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. |
Quantity in Commerce | 1 |
Distribution | The devices were not distributed in the United States.
The devices were distributed to the following foreign countries: Great Britain. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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