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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80421

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 29, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corp.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

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.

Z-2592-2018
Recall number
Z-2592-2018
Initiated
June 29, 2018
Classification
Class II
Status
Terminated
Quantity
409 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Code information

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

Distribution pattern

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.

device · product 2 of 4

MAYFIELD 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.

Z-2593-2018
Recall number
Z-2593-2018
Initiated
June 29, 2018
Classification
Class II
Status
Terminated
Quantity
17 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Code information

69626; 78445; 81360; 1526205; 1560439; 1610839; 1527910; 1560448; 1621857; 1959100; 2012964

Distribution pattern

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.

device · product 3 of 4

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.

Z-2594-2018
Recall number
Z-2594-2018
Initiated
June 29, 2018
Classification
Class II
Status
Terminated
Quantity
1 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Code information

CD-0436

Distribution pattern

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.

device · product 4 of 4

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.

Z-2595-2018
Recall number
Z-2595-2018
Initiated
June 29, 2018
Classification
Class II
Status
Terminated
Quantity
95 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

Code information

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

Distribution pattern

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.