HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular frac
FDA device recall Z-0282-2009 · posted 2008-11-04 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 10
- Distribution
- Nationwide and Canada
- Date initiated
- 2008-07-11
- Date posted
- 2008-11-04
- Date terminated
- 2009-09-11
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM (K001238) | Walter Lorenz Surgical, Inc. | 2000-05-03 |