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Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The… recallZ-2086-2013 · Alphatec Spine, Inc. · initiated Jun 28, 2013

Class II Terminated All recalls posted in August 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Alphatec Spine, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Equipment maintenance

What the company is doing

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 - [email protected] 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 [email protected].

Recall details

Recall number
Z-2086-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 28, 2013
Posted by the FDA
Aug 27, 2013
Recalling firm
Alphatec Spine, Inc.
Quantity
333 screws
Product code
NKB
FDA submissions
K123623
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.

Product description

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 (models, lots, serial numbers)

Part Number 73875-40. Lots Affected:  647289, 648923, 649244, 649556, 649813, 650040, 650262, 650589.

Other devices under the same FDA submission

10 devices cleared under K123623 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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