OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primar

FDA device recall Z-0472-2013 · posted 2012-12-04 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Action taken

The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580. Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HTO

Quantity affected

36

Distribution

Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.

Date initiated

2012-11-01

Date posted

2012-12-04

Date terminated

2013-04-29

Location

Warsaw, IN