"***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.
This recall has been terminated (originally issued August 1, 2011).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- March 15, 2010
- Posted
- August 1, 2011
- Terminated
- November 9, 2011
- Recall Number
- Z-2913-2011
- Quantity
- 35
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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).
Distribution
Worldwide distribution: USA (nationwide) and countries of: Canada, Israel and South Africa.
Lot / Code Info
Lot 064980
Root Cause
Nonconforming Material/Component
Action Taken
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.