| Class 2 Device Recall lllico Ti Cannulated Polyaxial Screw | |
Date Initiated by Firm | June 28, 2013 |
Date Posted | August 27, 2013 |
Recall Status1 |
Terminated 3 on October 09, 2014 |
Recall Number | Z-2086-2013 |
Recall Event ID |
65672 |
510(K)Number | K123623 |
Product Classification |
Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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Product | Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. |
Code Information |
Part Number 73875-40. Lots Affected: 647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589. |
Recalling Firm/ Manufacturer |
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad CA 92008-8816
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For Additional Information Contact | 760-431-9286 |
Manufacturer Reason for Recall | The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 40mm implants, due to an off-center cannulation hole at the proximal end of the bone screw. There is a potential risk that when the screw is mated to a polyaxial screwdriver, the guide wire may not pass through the screwdriver. |
FDA Determined Cause 2 | Equipment maintenance |
Action | The firm, Alphatec Spine, sent an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" with response sheet dated June 28, 2013 via a combination of e-mail, Fedex, and telephone contact to its customers. The notification described the product, problem and actions to be taken. The customers were instructed to immediately return any and all affected lots of the illico Ti Cannulated Polyaxial Screw 7.5 mm x 40 mm implants that have been sent to them; if the device has previously been implanted, there is no further or additional risk post-implantation; immediately contact Alphatec Spine Customer Service Department - customerservice@alphatecspine.com on how to replace the implants; and complete and return the last page of the notification via mail to Alphatec Spine, Inc. 5818 El Camino Real, Carlsbad, CA 92008; email: sarrhenius@alphatecspine or fax to: (760) 431-0289.
If you have any questions or need any additional information, please contact Director of Compliance at 760-494-9636 or email at dmcgrath@alphatecspine.com. |
Quantity in Commerce | 333 screws |
Distribution | Worldwide distribution: US (nationwide) including states of:US states: AZ, CA, FL, GA, IL, MD, NJ, NY, OK, PA, TN, TX,and WA ; and countries of: Spain, France, Japan.
International: Spain, France, Japan. |
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 = NKB
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