Class II — Integra LifeSciences Corporation
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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. |
| Quantity | 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, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and DC. (25 government consignees) and in the foreign countries: CANADA, ALGERIA, ARAB EMIRATES, AUSTRAL… |
| Initiated | 2014-12-19 |
| Classified | 2015-02-10 |
| Terminated | 2017-02-22 |
| Recall number | Z-1084-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corporation (Z-1084-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70088/
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