Class 2 Device Recall Mayfield Skull Clamp A2000

• Date Initiated by Firm: November 11, 2020
• Create Date: December 08, 2020
• Recall Status: Terminated on June 17, 2021
• Recall Number: Z-0548-2021
• Recall Event ID: 86845
• 510(K)Number: K932807
• Product Classification: Holder, head, neurosurgical (skull clamp) - Product Code HBL
• Product: Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
• Code Information: Rev Version B, Rev C and Rev D
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Lacey Gigante; 609-275-0500
• Manufacturer Reason for Recall: Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HBL and Original Applicant = OHIO MEDICAL INSTRUMENT CO., INC.