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U.S. Department of Health and Human Services

Class 2 Device Recall Attune Posterior (PS) Fixed Bearing (FB) Tibial Inserts

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  Class 2 Device Recall Attune Posterior (PS) Fixed Bearing (FB) Tibial Inserts see related information
Date Initiated by Firm February 15, 2023
Date Posted March 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-1267-2023
Recall Event ID 91752
510(K)Number K111433  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive - Product Code OIY
Product Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Code Information GTIN: 10603295049944; Lot: JN6613
Recalling Firm/
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact DePuy Synthes Sales Consultant.
Manufacturer Reason
for Recall
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
FDA Determined
Cause 2
Labeling Change Control
Action An URGENT MEDICAL DEVICE RECALL (REMOVAL) notification letter dated 2/14/23 was delivered to customers. Please Take the Following Steps: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject products. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to OneMD-Field-Actions@its.jnj.com within three (3) business days of receipt of this notification. Please include FA 2220700 Attune Inserts in the e-mail subject line. ¿ IMPORTANT: Please complete the attached Business Response Form even if you do not have any units of the subject product on hand. 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 subject products). 5. If any of the subject product has been forwarded to another facility, contact that facility, and provide them with a copy of this notice. 6. Post a copy of this notice in a visible area for awareness and keep a copy for your records. 7. As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program: " Online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda Health care providers who have treated patients using the products subject to this removal should continue to follow those patients pursuant to the health care provider s standard of care and may consider more frequent follow-up depending on the activity level and needs of an individual patient. For questions, or to consult with an in-house DePuy Synthes physician on this issue, please submit a Medical Information Request via our website: https://www.jnjmedicaldevices.com/mi
Quantity in Commerce 12 units
Distribution Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OIY and Original Applicant = DEPUY ORTHOPAEDICS, INC.