Date Initiated by Firm |
May 10, 2008 |
Date Posted |
June 05, 2013 |
Recall Status1 |
Terminated 3 on October 08, 2014 |
Recall Number |
Z-1482-2013 |
Recall Event ID |
64991 |
Product Classification |
Impactor - Product Code HWA
|
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. |
Code Information |
Lot number: 20856 |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
|
For Additional Information Contact |
Nicole Baginski 978-232-3990
|
Manufacturer Reason for Recall |
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
|
FDA Determined Cause 2 |
Process design |
Action |
Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution. |
Quantity in Commerce |
10 |
Distribution |
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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