Go-EZ Screw 6.5x115, Item Number 19671 - 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
This recall has been terminated (originally issued June 25, 2019).
- Company
- Biopro, Inc.
- Recall Initiated
- June 25, 2019
- Terminated
- May 7, 2020
- Recall Number
- Z-2253-2019
- Quantity
- 2 units
- Firm Location
- Port Huron, MI
- Official Source
- View on FDA website ↗
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 - M209196710 Lot Number - 123118 MFG Date - 4/25/2019
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.