Recall Z-2239-2019 ยท NBH Accessories, Arthroscopic
BioPro, Inc.
K-Wire HBS Sterile, Item Number 19688 - 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.
| Date | Jun 25, 2019 |
| Status | Terminated |
| Reason | Manufacturing flaw in the sterile barrier system |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 17 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW Biopro, Inc., Jun 3, 2010 |