FDA recall Z-1170-2023

Wright Medical Technology, Inc. · Class II · device

Product

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

US Nationwide distribution in the state of NY.

Key facts

Status
Ongoing
Initiation date
2023-02-02
Report date
2023-03-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1170-2023