HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical.… recallZ-0282-2009 · Biomet Microfixation, Inc. · initiated Jul 11, 2008
Terminated All recalls posted in November 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet Microfixation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0282-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 11, 2008
- Posted by the FDA
- Nov 4, 2008
- Recalling firm
- Biomet Microfixation, Inc.
- Quantity
- 10
- Product code
- JEY
- FDA submissions
- K001238
- Distribution
- Nationwide and Canada
Product description
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.
Code information (models, lots, serial numbers)
Lot 493200
Other devices under the same FDA submission
7 devices cleared under K001238 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 2.4MM SYSTEM 91-2710Biomet Microfixation, Inc · Plate, Bone37 reports
- 2.4MM SYSTEM 91-2708Biomet Microfixation, Inc · Plate, Bone21 reports
- 2.4MM SYSTEM 91-2712Biomet Microfixation, Inc · Plate, Bone8 reports
- 2.4MM SYSTEM 81-2710Biomet Microfixation, Inc · Plate, Bone1 report
- 2.4MM SYSTEM 91-2716Biomet Microfixation, Inc · Plate, Bone1 report
- 2.4MM SYSTEM 91-2714Biomet Microfixation, Inc · Plate, Bone1 report
- 2.4MM SYSTEM 91-2718Biomet Microfixation, Inc · Plate, Bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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