Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2013 - (Recall #: Z-2200-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

Product Classification:

Class II

Date Initiated: August 12, 2013

Date Posted: September 25, 2013

Recall Number: Z-2200-2013

Event ID: 66010

Reason for Recall:

One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.

Status: Terminated

Product Quantity: 9 units

Code Information:

RS12K008

Distribution Pattern:

USA Nationwide Distribution in the state of GA, AK, WA, and CA.

Voluntary or Mandated:

Voluntary: Firm initiated