Z-0548-2021Class II

Instruction Manual for Mayfield A2000 Skull Cap -

Name: Z-0548-2021 Instruction Manual for Mayfield A2000 Skull Cap -
Creator: Integra LifeSciences Corp.
Published: 2020-11-11
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2020-11-11 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000 on 2020-11-11. FDA classified it as Class II and gives the reason as "Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0548-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Posted: 2020-12-08
Terminated: 2021-06-17
Recalling firm: Integra LifeSciences Corporation
Product: Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
Reason for recall: Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Integre Life Sciences issued Voluntary Medical Device Correction via fedex mailing 2day (US customers) on 11/11/2020, stating reason for recall, health risk, and action to take: Customers: a. Please review and understand the information provided on the first page of this letter. b. Review the Mayfield Skull Clamp Position Diagram in the Instruction Manual for Part# 451A2000, Rev B through D (last page of each language in Instruction Manual). c. Replace the information in Mayfield Skull Clamp Position Diagram in the Instruction Manual, Part# 451A2000 with the information provided under Accurate Mayfield Skull Clamp Positioning Diagram, as appropriate. d. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. 2. Distributors: a. Review your inventory and determine if you have any of the manuals for Part# 451A2000, Rev B through D (last page of each language in Instruction Manual). b. Once identified, we recommend you review and understand the information provided on the first page of this letter. c. Please check your customer traceability records for shipments of the above catalog number. d. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. e. Forward a copy of the enclosed Field Safety Correction to any of your customers that have purchased the above catalog number. Integra is sending this notification to existing customers as an immediate correction and all future productsdistributed will contain the updated and accurate Instruction Manual. The Instruction Manual, Part # 451A2000 has been updated with the information on the first page. Please see the link below to access the complete Instruction Manual with the updated Mayfield Skull Clamp Position Diagram: https://www.integralife
Quantity in commerce: 552 units
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.
Product codes and lots: Rev Version B, Rev C and Rev D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0548-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0548-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-08

Product code HBL

K932807Class IIMayfield* a-2000 Skull ClampOhio Medical Instrument Co., Inc. / cleared 1993-09-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)