Z-0282-2009

HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of...

Name: Z-0282-2009 HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of...
Creator: Biomet Microfixation, Inc.
Published: 2008-07-11
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2008-07-11 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, Inc. began a recall of HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive... on 2008-07-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0282-2009
Status: Terminated
Initiated: 2008-07-11
Posted: 2008-11-04
Terminated: 2009-09-11
Recalling firm: Biomet Microfixation
Product: 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.
Product code: JEY Plate, Bone
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 10
Distribution: Nationwide and Canada
Product codes and lots: Lot 493200

Product code JEY

K001238Class IILorenz Titanium Fracture / Reconstruction Plating SystemWalter Lorenz Surgical, Inc. / cleared 2000-05-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)