Recall Z-1151-2010 ยท JEY Plate, Bone
Biomet Microfixation, Inc.
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), r
| Date | Mar 17, 2010 (initiated Oct 6, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 831 screws |
| Distribution | Worldwide Distribution -- United States (WI), Spain, Italy, Japan, Brazil and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM Walter Lorenz Surgical, Inc., Sep 28, 1995 |