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U.S. Department of Health and Human Services

Class 2 Device Recall SLIFT

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 Class 2 Recall
SLIFT
see related information
Date Posted July 05, 2013
Recall Status1 Open
Recall Number Z-1665-2013
Recall Event ID 65429
Premarket Notification
510(K) Number
K092815 
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
Code Information Lot/Serial Numbers: 47175
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
For Additional Information Contact Helen Moon
978-232-3990
Manufacturer Reason
for Recall
The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
FDA Determined
Cause 2
DESIGN: Device Design
Action Spine Frontier sent an Urgent Advisory Notice letter dated On June 7, 2013 to all consignees via email. The letter identified the affected product, problem and actions to be taken. The letter informed consignees that a modification has been implemented to the Outer Sleeve component of the S-LIFT Inserter and that SpineFrontier has initiated removal of the affected product from the field.. An acknowledgement form is to be signed and returned from each recipient of the Advisory Notice. Upon receipt of the acknowledgement form and RMA request for part return, replacement parts will be shipped. For questions call 978-232-3990.
Quantity in Commerce 12 devices
Distribution USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
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 = LXH and Original Applicant = SPINEFRONTIER, INC.
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