Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Tri

FDA device recall Z-1211-03 · posted 2003-09-11 · Terminated

Recall details

Recalling firm

Exactech, Inc.

Reason for recall

Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used.

Action taken

A recall letter dated July 31, 2003, requesting return of certain Tibial Augmentation Block Trials and an advisory (Field Advisory K-078) on the use of certain Tibial Tray Trials and Trapezoid Tibial Tray Trials. The recall letter gives the address to return product as: Exactech, 2243 NW 66th Court, Gainesville, FL. Consignees were told to immediately cease distribution or use of the recalled products and to return them. Also the letter asks them to extend the recall information to their user accounts and to read and comply with the instructions provided in the attached 'Field Advisory K-078'. This advisory instructs the dealers and users on the use of the devices to avoid problems.

Root cause

Other

Status

Terminated

Product code

LXH

Quantity affected

169

Distribution

Nationwide. Also the products were distributed to three intenational accounts in Spain, Japan and China.

Date initiated

2003-08-01

Date posted

2003-09-11

Date terminated

2012-05-03

Location

Gainesville, FL