Z-1685-2013Class II

Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model...

Name: Z-1685-2013 Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model...
Creator: Integra LifeSciences Corp.
Published: 2013-02-01
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-02-01 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corp. began a recall of Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation... on 2013-02-01. FDA classified it as Class II and gives the reason as "The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1685-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Posted: 2013-07-11
Terminated: 2013-07-25
Recalling firm: Integra LifeSciences Corporation
Product: Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Product code: LRZ Screwdriver, Surgical
Reason for recall: The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent recall notification letters to all consignees via traceable email or traceable fax on 02/01/13. The firm requested that the consignees fill out and return the Recall Acknowledgement and Return Form.
Quantity in commerce: 154 screwdrivers were distributed; 67 screwdriver tips were distributed.
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.
Product codes and lots: The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1685-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1685-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-11

Product code LRZ

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)