FDAFDA · Food and drugs·Recall number Z-2107-2023
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Published July 19, 2023 · Recall initiated: May 31, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Osteomed, LLC
- Distributor
- 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.
- Lot
- Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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