Date Initiated by Firm | May 24, 2013 |
Date Posted | July 05, 2013 |
Recall Status1 |
Terminated 3 on October 08, 2014 |
Recall Number | Z-1665-2013 |
Recall Event ID |
65429 |
510(K)Number | K092815 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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 MA 01915-6516
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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 | 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 |
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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 = LXH
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