CLASS II ONGOING Device recall · Reported 29 Mar 2023 · FDA Enforcement Report

Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled

DePuy Orthopaedics is recalling Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5, distributed nationwide in the US. The recall was initiated on 15 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 10603295049944; Lot: JN6613

Quantity recalled12 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1267-2023
FDA event ID: 91752
Recalling firm: DePuy Orthopaedics, Warsaw, IN
Classification: Class II
Status: Ongoing
Recall initiated: 15 Feb 2023
FDA classified: 17 Mar 2023
Reported: 29 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

15 Feb 2023	Recall initiated by company
17 Mar 2023	Classified by FDA	+30 days
29 Mar 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

GTIN: 10603295049944; Lot: JN6613

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 91752

This product is part of a recall event; the main page for the event is Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM recalled.

Reported	Class	Recall	Company	Reason	Where
29 Mar 2023	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM recalled	DePuy Orthopaedics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide