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U.S. Department of Health and Human Services

Class 2 Device Recall Dorado Straight Impactor

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 Class 2 Recall
Dorado Straight Impactor
see related information
Date Posted June 05, 2013
Recall Status1 Open
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, Massachusetts 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
DESIGN: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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