Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 25, 2013
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.
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 Sy…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Sofamor Danek USA Inc recalled T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal D… - a moderate-severity action.
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal D… was recalled by Medtronic Sofamor Danek USA Inc in September 25, 2013. Reason: One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal hea…. Check the official notice for the remedy. Verify recall #Z-2200-2013 with the FDA Devices before acting.
The recall
Medtronic Sofamor Danek USA Inc issued this moderate-severity FDA Devices recall-One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal hea….
- Moderate
- severity level
- 9 units
- affected scope
- Class II
- classification
- September 25, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2200-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2200-2013) was formally reported on September 25, 2013, with the manufacturer initiating the action on August 12, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Sofamor Danek USA Inc is listed as the recalling firm, operating out of Memphis, TN. Federal records list the affected scope as 9 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: USA Nationwide Distribution in the state of GA, AK, WA, and CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
9 units
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2200-2013 |
| Date reported | September 25, 2013 |
| Date initiated | August 12, 2013 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Firm location | Memphis, TN |
| Affected scope | 9 units |
| Distribution | USA Nationwide Distribution in the state of GA, AK, WA, and CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2200-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 9 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2200-2013.
Where was the recalled product distributed? ▼
Distribution: USA Nationwide Distribution in the state of GA, AK, WA, and CA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2200-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 25, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.