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U.S. Department of Health and Human Services

Class 2 Device Recall ATTUNE Revision Tibial Augment Size 7/8 5mm

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 Class 2 Device Recall ATTUNE Revision Tibial Augment Size 7/8 5mmsee related information
Date Initiated by FirmSeptember 09, 2021
Create DateOctober 07, 2021
Recall Status1 Terminated 3 on August 09, 2023
Recall NumberZ-0074-2022
Recall Event ID 88722
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Code Information Lot Number: J6304Z GTIN: 10603295057642
Recalling Firm/
Manufacturer		 DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactSAME
574-267-8143
Manufacturer Reason
for Recall		Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
FDA Determined
Cause 2		Under Investigation by firm
ActionDePuy (Ireland) issued Urgent Medical Device Recall (Removal)letter via email to US Sales Offices/Distributors and US Hospitals on 9/9/21. Recall letters will be emailed to US Sales Offices/Distributors. US Hospitals will be contacted by sales consultants. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject lot and quarantine the product. 2. Return the subject product(s) using the normal returns process. Work with your sales consultant to return subject product(s) and to replace. To receive replacement product(s) or reimbursement, customers must return the products subject to this removal. 3. Review, complete all fields, sign, and return the attached business response form (BRF) on page 2 of this letter to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this Removal Letter. Please include in the email subject: FA 2010228 - ATTUNE Revision Tibial Augment Incorrect Screw Size Packaged. 4. Forward this Removal Letter to any personnel in your facility who need to be informed. 5. If any of the product(s) subject to this Removal have been forwarded to another facility, contact that facility and provide a copy of this Removal Letter to the relevant personnel. 6. Post a copy of this Removal Letter in a visible area for awareness of this Removal. If you have any questions, please contact your local DePuy Synthes Sales Consultant. For Medical Information request, please visit our website: https://www.jnjmedicaldevices.com/mir.
Quantity in Commerce10 units
DistributionUS Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
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.
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