—#125848

Product

Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 239430, 239450

Why it was recalled

Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

The firm, BIOMET, sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated February 26, 2014 via Fed Ex overnight to domestic consignees. Australia and GSCC were notified by email and also received a hard copy letter via mail. The letter described the product, problem and actions to be taken. The letter stated that this action requires the immediate location and discontinued use of the product and its return to Biomet. The Consignees were were instructed to immediately locate, discontinue use of the product and remove the identified device(s) listed; carefully follow the instructions on the FAX Back Response Form and reply within three (3) business days; complete and return Form via Fax to: 574-372-1683 prior to return of product, and use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via enclosed "Dear Risk/Recall Manager Notice", and note that you are charged with the location and return of these products. Shipping address is Return Goods, 56 E. Bell Drive Warsaw, IN 46582. Questions related to the notice should be directed to 574-372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.

Timeline

Recall initiated: 2014-02-26
Posted by FDA: 2014-03-20
Terminated: 2015-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125848. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.