PlainRecalls
FDA Devices Moderate Class II Ongoing

ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device

Reported: March 8, 2023 Initiated: February 2, 2023 #Z-1170-2023

Product Description

ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, 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.

Details

Units Affected
4 units
Distribution
US Nationwide distribution in the state of NY.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 40241425, Bone fixation device. Recalled by Wright Medical Technology, Inc.. Units affected: 4 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 8, 2023. Severity: Moderate. Recall number: Z-1170-2023.