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.
FDA Recall Z-0282-2009 · Posted 2008-11-04
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Recalling FirmBiomet Microfixation, Inc.
Recall StatusTerminated
Product CodeJEY
Date Initiated2008-07-11
Date Terminated2009-09-11
Product Quantity10
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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