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Use caution Medical device recall · FDA · Published June 29, 2018

Integra MAYFIELD Spine Table Adaptor Risk: Knob Fracture During Use

Integra recalls MAYFIELD Infinity XR2 Base Unit adaptors (part A2600R) due to potential knob fracture during use. Affected units sold from 2018-2023; check serial numbers listed.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2595-2018Medical deviceIntegra ›
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Contact the company

Recalling firmIntegra LifeSciences Corp.311 Enterprise Dr · Plainsboro, NJ 08536-3344
✎ GovInfoNow plain-language explainer

Integra is recalling its MAYFIELD Infinity XR2 Base Unit adaptors (part A2600R) because the knob assembly might break during use. This could cause injury if the device becomes unstable during medical procedures. Read more at govinfonow.com/recall/70682-integra-mayfield-spine-table-adaptor-risk-knob-fracture-during-use.

Source Summary by GovInfoNow · govinfonow.com/recall/70682-integra-mayfield-spine-table-adaptor-risk-knob-fracture-during-use · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2595-2018

Cite this page

“Integra MAYFIELD Spine Table Adaptor Risk: Knob Fracture During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70682-integra-mayfield-spine-table-adaptor-risk-knob-fracture-during-use. Based on FDA recall #Z-2595-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2595-2018%22&limit=1).

Integra LifeSciences Corp. recalled the MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R, due to a potential fracture of the knob assembly during use, according to the FDA on June 29, 2018.

How to tell if you have it

  • Brand: Integra
  • Product: MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT
  • Part Number: A2600R
  • Units affected: 95

The hazard

The FDA stated there is a potential for the knob assembly in the swivel adapter to fracture or break during use.

Context

GovInfoNow's records show Integra LifeSciences Corp. has issued 35 other recalls since August 18, 2017. Recent similar product recalls include the Aju Pharm Genesis Dual Thread Screw-In Anchor Recall (December 17, 2025), the Zimmer Off-Axis Shoulder System Recall (May 20, 2026), and the Stryker Hoffmann II Connecting Rod Micro 3 x 50mm recall (July 1, 2026).

How to tell if you have this one

Check for the part number A2600R on the MAYFIELD Infinity XR2 Base Unit. Units sold between 2018 and 2023 with serial numbers listed in the recall notice are affected.

  • Brand
    Integra
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV; and to countries of:: Australia, Canada, China, Dominican Republic, Hong Kong, India, Japan, Korea, Malaysia, Mexico, Pakistan, Panama, Peru, Singapore, Sri Lanka, Taiwan, and Thailand.
Recall numberProduct, codes & lotsQuantity
Z-2592-2018MAYFIELD 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.; 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; 2781238409 units
Z-2593-2018MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E 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.; 69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 201296417 units
Z-2594-2018MAYFIELD 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.; CD-04361 units
Z-2595-2018MAYFIELD 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.; 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; 278130295 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Look for the serial numbers listed in the recall notice (e.g., 56487, 57300) on the device.

  2. Contact Integra for Details

    Reach out to Integra LifeSciences Corp. directly for specific guidance on affected units.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 44 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide Distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV;…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jun 29, 201812. FDA classified it Class II: Aug 1, 201823. Published in FDA’s Enforcement Report: Aug 8, 201834. FDA terminated the recall: Feb 26, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall for patients or only medical staff?

The recall affects medical devices used by healthcare professionals during procedures, not patients directly.

Do I need to stop using the device immediately?

The recall does not require immediate stop use; medical staff should monitor for knob fractures during procedures.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2595-2018 (June 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2595-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA