Z-1170-2023 Class II Ongoing

Recalled by Wright Medical Technology, Inc. — Memphis, TN

FDA device recall Z-1170-2023 was initiated by Wright Medical Technology, Inc. on February 2, 2023 and is designated Class II. 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. P… The recall status is ongoing. Affected quantity: 4 units.

Recall Details

Product Type
Devices
Report Date
March 8, 2023
Initiation Date
February 2, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 units

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.

Distribution Pattern

US Nationwide distribution in the state of NY.

Code Information

GTIN 00840420110770, Lot Number 1636042