Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants aft...
FDA Recall #Z-1482-2013 — Class II — May 10, 2008
Product Description
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.
Reason for Recall
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Recalling Firm
SpineFrontier, Inc. — Beverly, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10
Distribution
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Code Information
Lot number: 20856
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated