Recall Z-2243-2019 · NBH Accessories, Arthroscopic

BioPro, Inc.

K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - 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	350 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

This recall record lists no 510(k) number.