3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.
Check against the official notice below — it lists the full affected range.
TeDan Surgical Innovations LLC is recalling 3COR Distraction Screws (12 mm, sterile, 5 per box) used for spinal distraction procedures in the cervical spine. The recall affects 2,735 individual screws packaged in 547 boxes distributed worldwide, including throughout the United States and internationally to Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom. The screws are identified by Product Code D-0012, UDI Number 00843059121735, and Lot Numbers 2017110901, 2018021501, or 2018061101.
The recalled screws have a lack of pouch seal despite being labeled as sterile, which creates a potential sterility issue. The product recall record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Lack of pouch seal. Product is labelled as sterile.
Reason for recall: Lack of pouch seal. Product is labelled as sterile. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom. Quantity: 2735 individual screws (packaged into 547 boxes) - [5 screws per box] Lot/code info: Product Code: D-0012 UDI Number: 00843059121735 Lot Number: 2017110901 2018021501 2018061101
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.