Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 14, 2014
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fra…
SpineFrontier, Inc. recalled SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral B… — a moderate-severity action.
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral B… was recalled by SpineFrontier, Inc. in May 14, 2014. Reason: It has been verified through field use that there are two possible breakages that may occur when using SI5000…. Check the official notice for the remedy. Verify recall #Z-1565-2014 with the FDA Devices before acting.
The recall
SpineFrontier, Inc. issued this moderate-severity FDA Devices recall — It has been verified through field use that there are two possible breakages that may occur when using SI5000….
- Moderate
- severity level
- 30 units
- affected scope
- Class II
- classification
- May 14, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1565-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1565-2014) was formally reported on May 14, 2014, with the manufacturer initiating the action on December 23, 2011. 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 30 devices.
The documented reason for this recall is: It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impa… Distribution data in the federal record shows the product reached: US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO. 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, 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
30 devices
Related Recalls
6
6 from same agency
Product description
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Reason for recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1565-2014 |
| Date reported | May 14, 2014 |
| Date initiated | December 23, 2011 |
| Recalling firm | SpineFrontier, Inc. |
| Firm location | Beverly, MA |
| Affected scope | 30 devices |
| Distribution | US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO |
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-1565-2014) 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? ▼
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.. Recalled by SpineFrontier, Inc.. Units affected: 30 devices.
Why was this product recalled? ▼
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the ma
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2014. Severity: Moderate. Recall number: Z-1565-2014.
Where was the recalled product distributed? ▼
Distribution: US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1565-2014) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 14, 2014.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.