Date Initiated by Firm |
August 22, 2012 |
Date Posted |
November 21, 2012 |
Recall Status1 |
Terminated 3 on June 11, 2015 |
Recall Number |
Z-0417-2013 |
Recall Event ID |
63075 |
510(K)Number |
K092815
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Product Classification |
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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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.
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Code Information |
Lot Numbers: 012064-001 |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
|
For Additional Information Contact |
Mathew King 978-279-9271
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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
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = MAX and Original Applicant = SPINEFRONTIER, INC.
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