Recall Z-1169-2023— Wright Medical Technology, Inc.

Name: FDA recall Z-1169-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-02

Class II · Ongoing

Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2023-02-02. It names one FDA 510(k) clearance: K113014. Product: ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device. Reason: Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa..

Recalling firm: Wright Medical Technology, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-02-02
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K113014 — CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWSWrightmedicaltechnologyinc·cleared 2012-01-31

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

ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

Reason for recall

Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.

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