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Terminated

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.

FDA Recall Z-1957-2013 · Posted 2013-08-13

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeHXX
Date Initiated2012-05-09
Date Terminated2014-01-10
Product Quantity9

Reason for Recall

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

Distributed in DC and the states of MA, and OK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121060SPINE FRONTIER INDUS ACP SYSTEMSpinefrontier, Inc. · 2012-07-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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