Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- February 15, 2023
- Posted
- March 17, 2023
- Recall Number
- Z-1264-2023
- Quantity
- 7 units
- Firm Location
- Warsaw, IN
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Lot / Code Info
GTIN: 10603295490968; Lot: JP9016
Root Cause
Labeling Change Control
Action Taken
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