—#108716

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.

FDA product code: JXE — Device, Nerve Conduction Velocity Measurement
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K031280
Affected lot / code info: Catalog 423868 Lot 409680

Why it was recalled

Incorrect product picture label was on the product box.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Europe, Austrailia

Timeline

Recall initiated: 2012-04-18
Posted by FDA: 2012-05-10
Terminated: 2013-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108716. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.