Device product
REF 218-1604-SP-10, Profile 0 4mm AutoDrive Screw Sterile Qty 10, Rx Only, Sterile
Z-2108-2023
Product summary
- Firm
- Osteomed, LLC
- Event
- Event 92479
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2108-2023
Official wording
Reason: Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Code information: Lot # 1177274, 1177331, 1177823 / UDI-DI: (01)00845694066006
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.
Derived failure modes
-
Unknown
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.