Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended… recallZ-1521-2012 · Biomet, Inc. · initiated Apr 18, 2012
Terminated All recalls posted in May 2012
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, 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
Incorrect product picture label was on the product box.
FDA root cause category: Process design
What the company is doing
Biomet Orthopedics sent an Urgent Medical Device Recall Notice dated April 18,2012, to all affected customers. The letter identified the reason for the recall including directions to immediately locate, discontinue use of the device, and return product to Biomet, 56 East Bell Drive, Warsaw, IN 46580. Consignees were asked to confirm receipt of the notice by calling 1-800-348-9500 extension 3983 or 3009. A FAX Back Response Form was to be filled out and sent within 3 days of receipt to 574-372-1683. Questions related to the notice should be directed to 474-372-3983 or 574-371-3009, Monday- Friday 8 a.m. to 5 p.m. For questions regarding this recall call 574-371-1021.
Recall details
- Recall number
- Z-1521-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 18, 2012
- Posted by the FDA
- May 10, 2012
- Recalling firm
- Biomet, Inc.
- Quantity
- 30 units
- Product code
- JXE
- FDA submissions
- K031280
- Distribution
- Worldwide Distribution - USA (nationwide) and Europe, Austrailia
Product description
Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect Picture Label, Trochanter Plate (50-60 mm) Mallory/Head The Ultra-DriveTM System is used to aid in the removal of bone cement (PMMA) and noncemented implants in conjunction with revision arthroplasty. The Ultra-Drive" device converts standard electrical energy into mechanical energy, via an ultrasonic transducer in the Ultra-Drive" handpiece. This energy is transmitted through individually tuned tool tips in acoustic waves. causing the tool tip to vibrate at a controlled high speed. This action breaks down bone cement and cuts through cancellous bone.
Code information (models, lots, serial numbers)
Catalog 423868 Lot 409680
Other devices under the same FDA submission
4 devices cleared under K031280 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ULTRA-DRIVE TOOL 423859Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
- ULTRA-DRIVE TOOL 423836Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
- ULTRA-DRIVE TOOL 423864Biomet Orthopedics, LLC · Device, Nerve Conduction Velocity Measurement1 report
- ULTRA DRIVE III CONSOLE 423935Biomet Orthopedics, LLC · DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT1 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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