Z-1957-2013Class II

Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis...

Name: Z-1957-2013 Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis...
Creator: SpineFrontier, Inc.
Published: 2012-05-09
License: https://open.fda.gov/license/

SPINEFRONTIER, Inc. dba LESspine Innovations / initiated 2012-05-09 / Terminated / root cause: design

FDA source

SpineFrontier, Inc. began a recall of Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal... on 2012-05-09. FDA classified it as Class II and gives the reason as "The nipple of the tipped driver broke off when surgeons were attempting to insert the screw". 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-1957-2013
Classification: Class II
Status: Terminated
Initiated: 2012-05-09
Posted: 2013-08-13
Terminated: 2014-01-10
Recalling firm: SPINEFRONTIER, Inc. dba LESspine Innovations
Product: Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Product code: HXX Screwdriver
Reason for recall: The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Root cause tag: design
FDA root cause: Device Design
Action: On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.
Quantity in commerce: 9
Distribution: Distributed in DC and the states of MA, and OK.
Product codes and lots: Lot Number: 011836-0001, 011981-001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1957-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1957-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13

Product code HXX

K121060Class IISpine Frontier Indus Acp SystemSpinefrontier, Inc. / cleared 2012-07-03

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