Z-1319-2010

BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE...

Name: Z-1319-2010 BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE...
Creator: Biomet Microfixation, Inc.
Published: 2010-01-15
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2010-01-15 / Terminated / root cause: design

FDA source

Biomet Microfixation, Inc. began a recall of BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520... on 2010-01-15. The reason FDA records is "The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1319-2010
Status: Terminated
Initiated: 2010-01-15
Posted: 2010-04-11
Terminated: 2010-05-14
Recalling firm: Biomet Microfixation
Product: BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.
Product code: HWR Driver, Prosthesis
Reason for recall: The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees will be notified by letter on 01/15/2010 be either fax, email or mail.
Quantity in commerce: 73
Distribution: US ( AZ,CA,DC,FL,GA,ID,IL,IN,MO,NC,TX,UT), Japan, Finland, Africa
Product codes and lots: Lots: 459660, 478770, 530640.

Product code HWR

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

MDM coverage of this record lists here, newest first.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)