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Terminated

Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.

FDA Recall Z-1482-2013 · Posted 2013-06-05

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeHWA
Date Initiated2008-05-10
Date Terminated2014-10-08
Product Quantity10

Reason for Recall

During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

Firm Action

Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution.

Root Cause

Process design

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.

Official Source

View FDA Recall →

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

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