Lower riskMedical device recall · FDA · Published November 11, 2020
Integra Mayfield A200: Revised manual for skull clamp safety
Integra LifeSciences recalls revised instruction manuals for Mayfield A2000 skull cap. The update corrects illustrations for neurosurgical use to ensure safe rigid skeletal fixation.
“Integra Mayfield A200: Revised manual for skull clamp safety.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63930-integra-mayfield-a200-revised-manual-for-skull-clamp-safety. Based on FDA recall #Z-0548-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2021%22&limit=1).
Integra LifeSciences Corp. recalled Instruction Manuals for Mayfield A2000 Skull Caps due to inaccurate illustrations, according to the FDA. The agency announced the voluntary Class II recall on November 11, 2020. Owners should contact Integra for a revised manual.
How to tell if you have it
Brand: Integra LifeSciences
Product: Instruction Manual for Mayfield A2000 Skull Cap
Part Number: P/N: 451A2000
Revisions: Rev Version B, Rev C and Rev D
Units affected: 552 units
The hazard
The recalled manuals contain illustrations that do not reflect the most accurate depiction of the Mayfield Skull Clamp A2000 Position Diagram, according to the FDA.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since August 18, 2017. Other recent recalls of similar products include Integra AURORA Surgiscope System Recall (February 6, 2025), MediHoney Wound Dressing Gel Recall (January 10, 2025), and Integra LifeSciences CODMAN CERTAS Plus Valve Recall (December 16, 2024).
How to tell if you have this one
Check for the Mayfield A2000 skull cap with product number 451A2000. The manual is revised to versions B, C, or D.
Brand
Integra LifeSciences
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Manual Version
Check the manual version (B, C, or D) for the Mayfield A2000 skull cap with product number 451A2000.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0548-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0548-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.