Severity
Moderate
FDA Devices recall · Reported August 14, 2013
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
SpineFrontier, Inc. recalled T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are sili… - a moderate-severity action.
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are sili… was recalled by SpineFrontier, Inc. in August 14, 2013. Reason: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.. Check the official notice for the remedy. Verify recall #Z-1932-2013 with the FDA Devices before acting.
The recall
SpineFrontier, Inc. issued this moderate-severity FDA Devices recall-During an operation the strike plate of a T-Handle loosened and separated from the T-Handle..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1932-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1932-2013) was formally reported on August 14, 2013, with the manufacturer initiating the action on August 29, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. SpineFrontier, Inc. is listed as the recalling firm, operating out of Beverly, MA. Federal records list the affected scope as 11.
The documented reason for this recall is: During an operation the strike plate of a T-Handle loosened and separated from the T-Handle. Distribution data in the federal record shows the product reached: US Distribution including the states of MA, NV and TX.. 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.
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.
Severity
Moderate
Affected scope
11
Related Recalls
6
3 from same agency
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1932-2013 |
| Date reported | August 14, 2013 |
| Date initiated | August 29, 2012 |
| Recalling firm | SpineFrontier, Inc. |
| Firm location | Beverly, MA |
| Affected scope | 11 |
| Distribution | US Distribution including the states of MA, NV and TX. |
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.
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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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 August 14, 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.