Device product
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Z-0548-2021
Product summary
- Event
- Event 86845
- Status
- Terminated
- Classification
- Class II
- Quantity
- 552 units
- Official record key
device-enforcement:Z-0548-2021
Official wording
Reason: Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Code information: Rev Version B, Rev C and Rev D
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.
Derived failure modes
-
Unknown
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram