Date Initiated by Firm | August 29, 2012 |
Date Posted | August 08, 2013 |
Recall Status1 |
Terminated 3 on October 18, 2013 |
Recall Number | Z-1932-2013 |
Recall Event ID |
64993 |
510(K)Number | K092815 |
Product Classification |
Instrument, manual, surgical, general use - Product Code MDM
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Product | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A
T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients. |
Code Information |
Lot Numbers: 1335201A, 1446101A |
Recalling Firm/ Manufacturer |
SpineFrontier, Inc. 500 Cummings Ctr Ste 3500 Beverly MA 01915-6516
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For Additional Information Contact | Nicole Baginski 978-232-3990 |
Manufacturer Reason for Recall | During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. |
FDA Determined Cause 2 | Process design |
Action | On August 29, 2011, The Supply Chain Team was notified of the recall via email. They were informed that all handles are being pulled from the field. This resulted in the return of all T-Handles to SpineFrontier.
Further questions please call (978) 232-3990. |
Quantity in Commerce | 11 |
Distribution | US Distribution including the states of MA, NV 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 = MDM
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