FDA-Device2019-12-04Class II
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Wright Medical Technology, Inc.
Hazard
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Sold states
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Affected count
66 units
Manufactured in
11576 Memphis Arlington Rd, Arlington, TN, United States
Products
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief