Z-0548-2021 Class II Terminated

Recalled by Integra LifeSciences Corp. — Princeton, NJ

Recall Details

Product Type
Devices
Report Date
December 16, 2020
Initiation Date
November 11, 2020
Termination Date
June 17, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
552 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Rev Version B, Rev C and Rev D