RecallRadar

FDA Device recall Z-1957-2013

Invue Solid Driver, Tipped, AO. Part Number: 11-70083

On 2013-08-21 the FDA classified a Class II recall of Invue Solid Driver, Tipped, AO. Part Number: 11-70083 by Spinefrontier, citing the nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1957-2013
ClassificationClass II
Statusterminated
Initiated2012-05-09
Published2013-08-21
Last updated2026-09-13 11:53 UTC
CompanySpinefrontier
DistributionDC, MA, OK

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.

Reason

The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

Identifiers

code_infoLot Number: 011836-0001, 011981-001

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1957-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.