BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. Used along with implantable bone plates for oral, cranio-maxillofacial procedures including: Fractures, Osteotomies (including orthognathic procedures), reconstructive procedures & revision procedures where other treatments or devices have failed.
This recall has been terminated (originally issued March 17, 2010).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- October 6, 2009
- Posted
- March 17, 2010
- Terminated
- April 7, 2010
- Recall Number
- Z-1151-2010
- Quantity
- 831 screws
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.
Distribution
Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea.
Lot / Code Info
Lot Numbers: 813480, 114360, 498480, 753270, WL2340 and 031830.
Root Cause
Process control
Action Taken
Biomet Microfixation Issued an "Urgent Medical Device Recall Notice". Consignees were notified of the recall instructed to indentify and return all affected product to the firm. An Inventory Reconciliation sheet should be completed and faxed to 1-904-741-9425. For further information, contact Biomet Microfixation, Global Complaint Coordinator at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.