Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Reported: December 16, 2020 Initiated: November 11, 2020 #Z-0548-2021
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
Details
- Recalling Firm
- Integra LifeSciences Corp.
- Units Affected
- 552 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000. Recalled by Integra LifeSciences Corp.. Units affected: 552 units.
Why was this product recalled? ▼
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0548-2021.
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