Cylindrical Bullet Nose Reamer 10.5 mm x 250 mm, REF 475809, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The produc

FDA device recall Z-1532-2011 · posted 2011-03-04 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.

Action taken

The firm, BIOMET, sent an" URGENT MEDICAL DEVICE RECALL NOTICE" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683. Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.

Root cause

Other

Status

Terminated

Product code

HTO

Quantity affected

51 all products

Distribution

Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.

Date initiated

2010-12-23

Date posted

2011-03-04

Date terminated

2012-10-01

Location

Warsaw, IN