Date Initiated by Firm |
June 25, 2019 |
Create Date |
August 12, 2019 |
Recall Status1 |
Terminated 3 on May 07, 2020 |
Recall Number |
Z-2254-2019 |
Recall Event ID |
83288 |
510(K)Number |
K081149
|
Product Classification |
Accessories, arthroscopic - Product Code NBH
|
Product |
Go-EZ Screw 6.5x32, Item Number 19652 - 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 |
Code Information |
UDI - M209196520 Lot Number - 123106 MFG Date - 4/26/2019 |
Recalling Firm/ Manufacturer |
BioPro, Inc. 2929 Lapeer Rd Port Huron MI 48060-2558
|
For Additional Information Contact |
Kimberly Light 810-388-6010
|
Manufacturer Reason for Recall |
Manufacturing flaw in the sterile barrier system
|
FDA Determined Cause 2 |
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 in Commerce |
3 units |
Distribution |
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = NBH and Original Applicant = BIOPRO, INC.
|