The MAYFIELD¿ Ultra 360 Base Unit for head positioner — Class II medical device recall Z-1084-2015
Terminated recall by Integra LifeSciences Corporation, reported 2015-02-18, distributed nationwide. Through an investigation of complaints, Integra found that there is the possibility for the locking handle mec
| Recall number | Z-1084-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corporation, Cincinnati, OH, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-02-10 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2017-02-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CL, CN, DE, DK, DO, DZ, ES, FR, HK, HU, ID, IL, IN, IT, JO, JP, KR, LK, MX, NL, PL, PT, RO, SA, SG, SK, TH, TR, TW, ZA |
| Quantity | 1,053 units |
| Model numbers | 103127, 103128, 103129, 103130, 103131, 104890, 114978, 115809, 123051, 73149, 73355, 73356, 74396, 74398, 74399, 74523, 74524, 74730, 74890, 74892, 74893, 74894, 74895, 75796, 75816 and 104 more |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1084-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.