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Osteomed, LLC Recall 92479

Description: REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile

Osteomed, LLC Recall 92479 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2107-2023
Event ID92479
Event DescriptionREF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Product TypeDevices
DistributionWorldwide - 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.
Recall ReasonScrews for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
Device Classification20230719
Device Code InfoLot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258
Center Classification Date20230707
Recall Initiation Date20230531
Recalling FirmOsteomed, LLC
Initial Notification Letter
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