Z-2108-2023 Class II Ongoing
FDA device recall Z-2108-2023 was initiated by Osteomed, LLC on May 31, 2023 and is designated Class II. Reason for recall: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole. The recall status is ongoing. Affected quantity: N/A.
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-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 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 # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006