Z-1521-2012

Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile...

Name: Z-1521-2012 Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile...
Creator: Biomet, Inc.
Published: 2012-04-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-04-18 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581 Incorrect... on 2012-04-18. The reason FDA records is "Incorrect product picture label was on the product box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1521-2012
Status: Terminated
Initiated: 2012-04-18
Posted: 2012-05-10
Terminated: 2013-04-18
Recalling firm: Zimmer GmbH
Product: 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.
Product code: JXE Device, Nerve Conduction Velocity Measurement
Reason for recall: Incorrect product picture label was on the product box.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 30 units
Distribution: Worldwide Distribution - USA (nationwide) and Europe, Austrailia
Product codes and lots: Catalog 423868 Lot 409680

Product code JXE

K031280Class IIUltra-Drive 3Biomet, Inc. / cleared 2003-09-22

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)