REF: 218-1604 recall
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
Why was REF: 218-1604 recalled?
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 1177027, 1177718, 1177812 / UDI-DI: (01)00845694034258
- Product
- REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile
- Recalling firm
- Osteomed, LLC
- Quantity
- N/A
- Distribution
- 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.
- Recall date
- July 19, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)