Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and no

FDA device recall Z-0797-2016 · posted 2016-02-11 · Terminated

Recall details

Recalling firm

Orthofix, Inc

Reason for recall

There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.

Action taken

Affected consignees were notified via an Urgent Medical Device Recall Notification letter, dated 1/8/16. The letter identified the affected device and stated the reason for the recall. The recalling firm requests customers to remove the affected devices from their inventory and cease further distribution or use. Customers whom the devices were further distributed to should be notified that the affected devices cannot be used and must be returned to Orthofix per the instructions provided. The attached Acknowledgement Form should be completed and returned. Customers can contact their local Orthofix representative or customer service for further information, replacements, or disposal instructions.

Root cause

Component design/selection

Status

Terminated

Product code

HXC

Quantity affected

36 units

Distribution

Worldwide Distribution -- US, Spain, Italy, and Australia.

Date initiated

2016-01-08

Date posted

2016-02-11

Date terminated

2016-11-16

Location

Lewisville, TX

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