MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT — Class II medical device recall Z-2594-2018
Terminated recall by Integra LifeSciences Corp., reported 2018-08-08, distributed nationwide. There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
| Recall number | Z-2594-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2018-06-29 |
| Classified | 2018-08-01 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2020-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DO, HK, IN, JP, KR, LK, MX, MY, PA, PE, PK, SG, TH, TW |
| Quantity | 1 units |
| Reason classes | device malfunction |
| Model numbers | A2079A |
Product
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
Reason for recall
There is a potential for the knob assembly in the swivel adapter to fracture/break 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-2594-2018. 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.