FDA recall Z-0786-2022

Product

Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.

Reason for recall

An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

Distribution

International distribution to the country of France.

Key facts

Status

Terminated

Initiation date

2022-02-15

Report date

2022-03-23

Termination date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0786-2022