Z-1266-2023Class II

Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312

Name: Z-1266-2023 Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Creator: DePuy Orthopaedics, Inc.
Published: 2023-02-15
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2023-02-15 / Open, Classified / root cause: labeling and UDI

FDA source

DePuy Orthopaedics, Inc. began a recall of Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 on 2023-02-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1266-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-15
Posted: 2023-03-17
Recalling firm: Depuy Orthopaedics Inc.
Product: Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: 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 [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
Quantity in commerce: 7 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
Product codes and lots: GTIN: 10603295490869; Lot: JP6464

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1266-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1263-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17
Z-1264-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17
Z-1265-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17
Z-1266-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17
Z-1267-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17

Product code KRO

K191779Class IIAttune Revision LPS InsertsDepuy(Ireland) / cleared 2019-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)