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.
This recall has been terminated (originally issued November 4, 2008).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- July 11, 2008
- Posted
- November 4, 2008
- Terminated
- September 11, 2009
- Recall Number
- Z-0282-2009
- Quantity
- 10
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Canada
Lot / Code Info
Lot 493200
Root Cause
Labeling mix-ups
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.
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