FDA recall Z-2108-2023

Osteomed, LLC · Class II · device

Product

REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile

Reason for recall

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, KS, KY, MD, MO, MT, NE, NY, TN, TX and the country of SG.

Key facts

Status
Ongoing
Initiation date
2023-05-31
Report date
2023-07-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Addison, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2023