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U.S. Department of Health and Human Services

Class 2 Device Recall Center Drive Stainless Steel 2.0MM System Screwdriver Blade

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 Class 2 Recall
Center Drive Stainless Steel 2.0MM System Screwdriver Blade
see related information
Date Posted August 01, 2011
Recall Status1 Terminated on November 09, 2011
Recall Number Z-2913-2011
Recall Event ID 58920
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Blade used to implant screws.
Code Information Lot 064980
Recalling Firm/
Manufacturer
Biomet Microfixation, Inc.
1520 Tradeport Dr
Jacksonville, Florida 32218-2480
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Laura Sabo
904-741-4400
Manufacturer Reason
for Recall
Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws).
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm, Biomet Microfixation, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" undated letter to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the affected products and immediately return them to Biomet Microfixation, Attn: Global Complaint Coordinator, 1520 Tradeport Drive, Jacksonville, FL 32218-2480; complete and return the Inventory Reconciliation sheet via Fax to the attention of: Global Complaint Coordinator at 904-741-9425, and notify their customers if product was further distributed. If you have any questions, contact the Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
Quantity in Commerce 35
Distribution Worldwide distribution: USA (nationwide) and countries of: Canada, Israel and South Africa.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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