3COR DISTRACTION SCREW, 14 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, 14 mm, sterile, packaged 5 per box. The screws are intended for use in distraction procedures during anterior cervical spine surgery. The recall affects 387 boxes (1,935 total screws) with lot numbers 2018020801 and 2018080601, identified by product code D-0014 and UDI number 00843059121742. These products were distributed worldwide, including throughout the United States and in Australia, Canada, France, Philippines, Taiwan, U.A.E., and the United Kingdom.
The reason for the recall is a lack of pouch seal on the product, despite the screws being labeled as sterile. The record does not specify a remedy or instructions 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: 1935 screws (packaged into 387 boxes) - [5 screws per box] Lot/code info: Product Code: D-0014 UDI Number: 00843059121742 Lot Number: 2018020801 2018080601
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.