Recall Z-0282-2009 ยท JEY Plate, Bone
Biomet Microfixation, Inc.
HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
| Date | Nov 4, 2008 (initiated Jul 11, 2008) |
| Status | Terminated |
| Reason | The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW. |
| Root cause | Labeling mix-ups |
| Action | An "Urgent Medical Device Recall Notice" was sent to customers on 07/11/2008 by certified letter. The letter described the problem, the risk and asked that customers discontinue use of the product and return them to Biomet. Also, customers were provided with a Inventory Reconciliation sheet and asked to fax it back to Biomet. Please contact Biomet Microfixation at 1-800-874-771 or 904-741-4400, ext. 448 for assistance. |
| Quantity | 10 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM Walter Lorenz Surgical, Inc., May 3, 2000 |