Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only T

FDA device recall Z-1089-2014 · posted 2014-02-25 · Terminated

Recall details

Recalling firm

Orthofix, Inc

Reason for recall

There is a possibility that the locking mechanism of the Azure Anterior Cervical Plate may fracture during or after implantation.

Action taken

Orthofix sent a Urgent Medical Device Recall Notification dated October 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Action: 1. Immediately cease any further distribution or use of the AZURE" plates. 2. Notify your surgeons and staff customers that Azure" plates cannot be used and are to be returned to Orthofix. at no cost to you, see Instructions below. 3. Please complete the attached reply form indicating that you have received this letter. Product Return Instructions: To return the Azure plates, please follow these Instructions. 1. Check you inventory of Azura Implant Trays.. 2. Complete the attached form with the quantity you are returning. 3. Contact your local Orthofix representative or Orthofix customer service representative at 888--298-5700 for return instructions and shipment information and replacement with a different Orthofix Anterior Cervical Plate System. .

Root cause

Component design/selection

Status

Terminated

Product code

KWQ

Quantity affected

4,172 units

Distribution

Worldwide Distribution: USA (nationwide) and the country of Germany.

Date initiated

2013-10-29

Date posted

2014-02-25

Date terminated

2014-12-09

Location

Lewisville, TX

Related 510(k) clearances