—#103982

Product

MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA. This device is used to mark the femoral neck resection level

FDA product code: FZX — Guide, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Part 31-555597, lot numbers: 476500, 572420, 663220, 812350, & 472890.

Why it was recalled

Biomet has initiated this action following an investigation which identified that the blueprint calls for engraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. The above lots, as supplied to Biomet by a vendor, are engraved on only one side. To date, Biomet has received 2 reports involving 2 units where the instrument was missing the engraving on one side.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Arrangements will be made for customers to return the affected product to Biomet. To confirm receipt of this notice call Biomet at 800-348-9500 ext. 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 3756, Monday through Friday, 8 AM to 5 PM.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile.

Timeline

Recall initiated: 2011-09-16
Posted by FDA: 2011-10-20
Terminated: 2013-03-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103982. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.