ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
FDA Recall #Z-1169-2023 — Class II — February 2, 2023
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.
Recalling Firm
Wright Medical Technology, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10 units
Distribution
US Nationwide distribution in the state of NY.
Code Information
GTIN 00840420152985, Lot Number 1636048
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated