Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
- Company
- Biopro, Inc.
- Recall Initiated
- June 25, 2019
- Terminated
- May 7, 2020
- Recall Number
- Z-2251-2019
- Quantity
- 2 units
- Firm Location
- Port Huron, MI
Reason for Recall
Manufacturing flaw in the sterile barrier system
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Lot / Code Info
UDI - M209196650 Lot Number - 123112 MFG Date - 4/26/2019
Root Cause
Nonconforming Material/Component
Action Taken
On 6/25/2019, BioPro contacted all customers via telephone. BioPro subsequently emailed all customers a list of impacted products to include details of how products should be returned and actions to be taken. Customers were advised to take the following action: 1) Identify and segregate impacted product. 2) BioPro will send a return shipping label to facilitate a smooth return of product. Reference RMA # when product is returned. Customers with questions may call 1-800-252-7707.