Recall Z-1482-2013— SpineFrontier, Inc.
Class II · Terminated
Class II FDA medical device recall by SpineFrontier, Inc., initiated 2008-05-10, terminated 2014-10-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: During two separate occasions an impactor plate on the handle broke off while being struck by a mallet..
- Recalling firm
- SpineFrontier, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2008-05-10
- Terminated
- 2014-10-08
- Firm location
- Beverly, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.