Z-2107-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2023
- Initiation Date
- May 31, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, 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 Pattern
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.
Code Information
Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258