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U.S. Department of Health and Human Services

Class 2 Device Recall SIW Patient Specific Distal Femur device

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  Class 2 Device Recall SIW Patient Specific Distal Femur device see related information
Date Initiated by Firm April 12, 2016
Date Posted May 09, 2016
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-1623-2016
Recall Event ID 73856
Product Classification Distal Femoral Replacement - Product Code JWH
Product Distal Femoral Replacement (patient specific, custom made orthopedic implant device). PIN 19960
Code Information Device Identifier: PIN 19960, Lot: 19960
Recalling Firm/
Manufacturer		 Stanmore Implants Worldwide Ltd.
210 Centennial Avenue Centennial Park
Centennial Park
Borehamwood United Kingdom
Manufacturer Reason
for Recall		 Incorrect component used to manufacture distal femoral replacement.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action A notification was sent to the prescribing physician on 04/12/2016.
Quantity in Commerce 1
Distribution US distribution to OH.
Total Product Life Cycle TPLC Device Report
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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