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U.S. Department of Health and Human Services

Class 2 Device Recall THandle

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 Class 2 Recall
THandle
see related information
Date Posted August 08, 2013
Recall Status1 Terminated on October 18, 2013
Recall Number Z-1932-2013
Recall Event ID 64993
Premarket Notification
510(K) Number
K092815 
Product Classification Instrument, Manual, Surgical, General Use - Product Code MDM
Product T-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, Massachusetts 01915-6516
For Additional Information Contact Nicole 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
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control
Action On 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 Commerce 11
Distribution US Distribution including the states of MA, NV and TX.
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.
510(K) Database 510(K)s with Product Code = MDM and Original Applicant = SPINEFRONTIER, INC.
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