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U.S. Department of Health and Human Services

Class 2 Device Recall SLIFT Slap Hammer

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 Class 2 Recall
SLIFT Slap Hammer
see related information
Date Posted August 01, 2013
Recall Status1 Terminated on January 09, 2014
Recall Number Z-1870-2013
Recall Event ID 65033
Product Classification Hammer, Surgical - Product Code FZY
Product S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
Code Information Lot: 56H26
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
Malfunction of slap hammer.
FDA Determined
Cause 2
DESIGN: Device Design
Action The firm, SpineFrontier, sent an advisory notice entitled "URGENT April 25, 2013 S-LIFT Slap Hammer Removal" dated April 25, 2013 via email to its customers. The notice described the product, problem and action to be taken. The notice requested the removal of all distributed SLIFT Slap Hammer with listed lot number. The customers were instructed to complete and return the URGENT S-LIFT Slap Hammer Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email to customerservice@spinefrontier.com. Please feel free to contact SpineFrontier at 978-232-3990 with any questions.
Quantity in Commerce 3
Distribution US distributions to states of: KS 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.
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