FDA Device recall Z-2595-2018
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patie…
- FDA Device
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patie… 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-2595-2018 |
| 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 SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R 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 | 56487; 57300; 57825; 58248; 59022; 59844; 61783; 61850; 62702; 63701; 64835; 66039; 66914; 68778; 81912; 85485; 86195;…56487; 57300; 57825; 58248; 59022; 59844; 61783; 61850; 62702; 63701; 64835; 66039; 66914; 68778; 81912; 85485; 86195; 88511; 1501445; 1664646; 1584488; 1713505; 1959097; 2076251; 2337182; 2450911; 2556851; 2664422; 2798806; 2798981; 2647413; 2781302 |
|---|
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-2595-2018%22
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