Z-0489-2010

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

Name: Z-0489-2010 LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET...
Creator: Biomet Microfixation, Inc.
Published: 2009-09-15
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2009-09-15 / Terminated

FDA source

Biomet Microfixation, Inc. began a recall of LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL... on 2009-09-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0489-2010
Status: Terminated
Initiated: 2009-09-15
Posted: 2010-01-04
Terminated: 2010-01-23
Recalling firm: Biomet Microfixation
Product: LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. Lacto Sorb 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 Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone.
Product code: HWC Screw, Fixation, Bone
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.
FDA root cause: Component change control
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.
Quantity in commerce: 15 pieces
Distribution: USA - FL, MO, and KS; Foreign: Brazil and China.
Product codes and lots: Lot Number: 064350

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)