PlainRecalls
FDA Devices Moderate Class II Terminated

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

Reported: December 4, 2019 Initiated: November 8, 2016 #Z-0568-2020

Product Description

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

Reason for Recall

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Details

Units Affected
66 units
Distribution
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain
Location
Arlington, TN

Frequently Asked Questions

What product was recalled?
Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514. Recalled by Wright Medical Technology, Inc.. Units affected: 66 units.
Why was this product recalled?
The firm discovered a lack of adequate documentation confirming sterility on certain products.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0568-2020.