LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 152

FDA device recall Z-0489-2010 · posted 2010-01-04 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.

Action taken

Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm. For further information, contact Biomet Microfixation at 1-904-741-9468.

Root cause

Component change control

Status

Terminated

Product code

HWC

Quantity affected

15 pieces

Distribution

USA - FL, MO, and KS; Foreign: Brazil and China.

Date initiated

2009-09-15

Date posted

2010-01-04

Date terminated

2010-01-23

Location

Jacksonville, FL