FDA Recall Terminated

LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. LactoSorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the bone.

Recall: Z-0490-2010 · Initiated September 15, 2009

Recall

Recall Number
Z-0490-2010
Event Number
53845
Firm
Biomet Microfixation, Inc.
FEI Number
1032347
Product Code
HWC
Status
Terminated
Root Cause
Component change control
Initiated
September 15, 2009
Posted
January 4, 2010
Terminated
January 23, 2010
Address
1520 Tradeport Dr, Jacksonville, FL, 32218-2480

Description

LACTOSORB SYSTEM 1.5MM ADJUSTABLE SELF-DRILLING TAP FOR POWER DRIVER, REF: 915-2185, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. LactoSorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the LactoSorb Bulbs Handles or Power Drivers to advance the Tap into the bone.

Reason

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

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.

Distribution

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

Quantity

7 pieces