Z-2200-2013Class II

T8 Removal Head, Ref 8910641, Qty: 1 Ea

Name: Z-2200-2013 T8 Removal Head, Ref 8910641, Qty: 1 Ea
Creator: Medtronic Sofamor Danek USA Inc
Published: 2013-08-12
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2013-08-12 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of 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... on 2013-08-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2200-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-12
Posted: 2013-09-14
Terminated: 2013-12-27
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: 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 code: HXX Screwdriver
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.
Quantity in commerce: 9 units
Distribution: USA Nationwide Distribution in the state of GA, AK, WA, and CA.
Product codes and lots: RS12K008

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2200-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2200-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-14

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)