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U.S. Department of Health and Human Services

Class 2 Device Recall THandle

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 Class 2 Device Recall THandlesee related information
Date Initiated by FirmAugust 29, 2012
Date PostedAugust 08, 2013
Recall Status1 Terminated 3 on October 18, 2013
Recall NumberZ-1932-2013
Recall Event ID 64993
510(K)NumberK092815 
Product Classification Instrument, manual, surgical, general use - Product Code MDM
ProductT-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Code Information Lot Numbers: 1335201A, 1446101A
Recalling Firm/
Manufacturer		 SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly MA 01915-6516
For Additional Information ContactNicole Baginski
978-232-3990
Manufacturer Reason
for Recall		During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
FDA Determined
Cause 2		Process design
ActionOn August 29, 2011, The Supply Chain Team was notified of the recall via email. They were informed that all handles are being pulled from the field. This resulted in the return of all T-Handles to SpineFrontier. Further questions please call (978) 232-3990.
Quantity in Commerce11
DistributionUS Distribution including the states of MA, NV and TX.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = MDM
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