—#184673

Product

Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000

FDA product code: HBL — Holder, Head, Neurosurgical (Skull Clamp)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K932807
Affected lot / code info: Rev Version B, Rev C and Rev D

Why it was recalled

Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.

Timeline

Recall initiated: 2020-11-11
Terminated: 2021-06-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184673. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.