Recall Z-1267-2023— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1267-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-15

Class II · Ongoing

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2023-02-15. It names one FDA 510(k) clearance: K111433. Product: Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507. Reason: 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..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-15
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEMDePuy Orthopaedics, Inc.·cleared 2011-08-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.