Z-0598-06

MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate...

Name: Z-0598-06 MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate...
Creator: Orthohelix Surgical Designs Inc
Published: 2005-11-01
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2005-11-01 / Terminated

FDA source

Orthohelix Surgical Designs Inc began a recall of MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System on 2005-11-01. The reason FDA records is "Screwdriver pilot taper tip can break during surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0598-06
Status: Terminated
Initiated: 2005-11-01
Posted: 2006-03-09
Terminated: 2012-04-25
Recalling firm: TORNIER Inc.
Product: MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Screwdriver pilot taper tip can break during surgery.
FDA root cause: Other
Action: Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.
Quantity in commerce: 14
Distribution: Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.
Product codes and lots: lot #11298

Product code HRS

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

Process control is the most common named cause of a device recall11 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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)