Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate th
FDA device recall Z-2086-2013 · posted 2013-08-27 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 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, Jap
- Date initiated
- 2013-06-28
- Date posted
- 2013-08-27
- Date terminated
- 2014-10-09
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ILLICO MIS POSTERIOR FIXATION SYSTEM (K123623) | Alphatec Spine, Inc. | 2013-02-14 |