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U.S. Department of Health and Human Services

Class 2 Device Recall SLIFT Extension Shims

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 Class 2 Recall
SLIFT Extension Shims
see related information
Date Posted November 14, 2013
Recall Status1 Open
Recall Number Z-0274-2014
Recall Event ID 65760
Premarket Notification
510(K) Number
K092815 
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
Code Information Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1
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
Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
FDA Determined
Cause 2
DESIGN: Device Design
Action SpineFrontier sent an Urgent Voluntary Recall letter dated August 28, 2013, to all affected customers. The letter identified teh product, the problem, and the action to be taken by the customer. Customers were asked to initiate the immediate return of the parts noted and complete an acknowledgement form and return it to SpineFrontier via fax or email. Customers with questions were instructed to call 978-232-3990. For questions regarding this recall call 978-232-3990.
Quantity in Commerce 67
Distribution Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
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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