Date Initiated by Firm | June 25, 2019 |
Create Date | August 12, 2019 |
Recall Status1 |
Terminated 3 on May 07, 2020 |
Recall Number | Z-2248-2019 |
Recall Event ID |
83288 |
510(K)Number | K081149 |
Product Classification |
Accessories, arthroscopic - Product Code NBH
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Product | Go-EZ Screw 6.5x36, Item Number 19654 - 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 - M209196540 Lot Number - 123108 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 |
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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.
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510(K) Database | 510(K)s with Product Code = NBH
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