FDA recall Z-0548-2021

Product

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

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

Key facts

Status

Terminated

Initiation date

2020-11-11

Report date

2020-12-16

Termination date

2021-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0548-2021