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U.S. Department of Health and Human Services

Class 2 Device Recall GoEz Screw

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  Class 2 Device Recall GoEz Screw see related information
Date Initiated by Firm June 25, 2019
Create Date August 12, 2019
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-2249-2019
Recall Event ID 83288
510(K)Number K081149  
Product Classification Accessories, arthroscopic - Product Code NBH
Product Go-EZ Screw 6.5x95, Item Number 19667 - 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 - M209196670 Lot Number - 123114 MFG Date - 4/25/2019
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 4 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.
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