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Terminated

Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.

FDA Recall Z-0575-2014 · Posted 2013-12-26

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeKWQ
Date Initiated2013-11-20
Date Terminated2018-09-06

Reason for Recall

Mismarked and unmarked screws

Firm Action

On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.

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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