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ATTUNE LPS recallZ-1265-2023 · DePuy Orthopaedics, Inc. · initiated Feb 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Labeling Change Control

What the company is doing

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 [email protected] 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

Recall details

Recall number
Z-1265-2023
Status
Open, Classified
Initiated by the company
Feb 15, 2023
Posted by the FDA
Mar 17, 2023
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
7 units
Product code
KRO
FDA submissions
K191779
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

Product description

Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226

Code information (models, lots, serial numbers)

GTIN: 10603295491033; Lot: JP9022

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 91752).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page