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…
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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026