FDA Devices recall · Reported February 18, 2015
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
Integra LifeSciences Corporation recalled The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product U… - a moderate-severity action.
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product U… was recalled by Integra LifeSciences Corporation in February 18, 2015. Reason: Through an investigation of complaints, Integra found that there is the possibility for the locking handle me…. Check the official notice for the remedy. Verify recall #Z-1084-2015 with the FDA Devices before acting.
The recall
Integra LifeSciences Corporation issued this moderate-severity FDA Devices recall-Through an investigation of complaints, Integra found that there is the possibility for the locking handle me….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1084-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1084-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on December 19, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Integra LifeSciences Corporation is listed as the recalling firm, operating out of Cincinnati, OH. Federal records list the affected scope as 1053 Units.
The documented reason for this recall is: Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV…. 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 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
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
Reason for recall
Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1084-2015 |
| Date reported | February 18, 2015 |
| Date initiated | December 19, 2014 |
| Recalling firm | Integra LifeSciences Corporation |
| Firm location | Cincinnati, OH |
| Affected scope | 1053 Units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR… |
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-1084-2015) 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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Methodology · Corrections · Archive as of August 2026