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U.S. Department of Health and Human Services

Class 2 Device Recall DePuy

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 Class 2 Device Recall DePuysee related information
Date Initiated by FirmJuly 01, 2021
Create DateAugust 25, 2021
Recall Status1 Terminated 3 on February 01, 2023
Recall NumberZ-2348-2021
Recall Event ID 88413
510(K)NumberK160700 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Code Information Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactSAME
574-267-8143
Manufacturer Reason
for Recall		Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
FDA Determined
Cause 2		Process change control
ActionDePuy Syntheses issued Medical Device Product Recall (Removal) Ref. 1986537 dated 7/1/21. Letter states reason for recall, health risk and action to take: Please take the Following Steps: 1.Examine your inventory immediately to determine if you have the subject lot and quarantine theproduct. 2.Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices or callcustomer service following the typical returns process in order to acquire a return number prior toshipping product. 3.Review, complete, sign, and return the attached business response form (page 3 of this letter) to your localDePuy Synthes sales organization in accordance with the directions on the form within 5 business days ofreceipt of this notification. 4.Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport,store, stock, or use the devices subject to this action). 5.If any of the subject lot has been forwarded to another facility, contact that facility and provide them with thisnotice. 6.Post a copy of this notice in a visible area for awareness and keep a copy for your records. Should you have any other inquiries please do not hesitate to contact your DePuy Synthes Sales Consultant.
Quantity in Commerce7 units
DistributionInternational distribution in the countries of Canada, France.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JWH
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