Osteomed, LLC 2023-07-19 Health serious FDA
Health · FDA · Recall #FDA-Z-2107-2023
REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile Recall
Issued July 19, 2023 · Osteomed, LLC
In July 2023, Osteomed, LLC recalled the REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.
What you should do
- 1 Stop using REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Osteomed, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Osteomed, LLC
- Category
- Health
- Recall date
- July 19, 2023
- Units affected
- Not reported
- Sold at
- 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 number
- FDA-Z-2107-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Osteomed, LLC has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.