FDA Device recall Z-2592-2018
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during…
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during… by Integra Lifesciences, citing there is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2592-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-29 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 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
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
Identifiers
| code_info | 57218; 58242; 59524; 61083; 61084; 61533; 61559; 62801; 63826; 63949; 65966; 65967; 66950; 67912; 70432; 70564; 74838;…57218; 58242; 59524; 61083; 61084; 61533; 61559; 62801; 63826; 63949; 65966; 65967; 66950; 67912; 70432; 70564; 74838; 76382; 78005; 79436; 79475; 81218; 84107; 86162; 88507; 89760; 1468037; 1558488; 1664697; 1755770; 1485531; 1726814; 1737849; 1795116; 1939414; 2051032; 2135345; 2162789; 2247499; 2353536; 2380794; 2450908; 2463223; 2497401; 2517644; 2556854; 2642914; 2642922; 2740222; 2760809; 2760810; 2781235; 2781238 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2592-2018%22
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