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U.S. Department of Health and Human Services

Class 2 Device Recall SLift Implant Guides

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 Class 2 Recall
SLift Implant Guides
see related information
Date Posted November 21, 2012
Recall Status1 Open
Recall Number Z-0417-2013
Recall Event ID 63075
Premarket Notification
510(K) Number
K092815 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
Product S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
Code Information Lot Numbers: 012064-001
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
For Additional Information Contact Mathew King
978-279-9271
Manufacturer Reason
for Recall
When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Spine Frontier issued a Correction Notice Letter August 22, 2012 to all affected customers to update the Instructions for Use. The letter identified the affected product, problem and actions to be taken. Customers were Instructed to remove the Instructions for Use they currently have and replace them with the update. The letter instructs customers to complete and return the Response Form to 978-232-3990.
Quantity in Commerce 19 units
Distribution US Nationwide including the states of: MA 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 = MAX and Original Applicant = SPINEFRONTIER, INC.
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