Reported Dec 16, 2020 · Terminated
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- Instruction Manual for Mayfield
- A2000 Skull Cap - Product Usageintended for or rigid skeletal fixation during neurosurgical procedures
- P/N451A2000
- Lot codes and dates
- Rev Version B, Rev C and Rev D
- Amount recalled
- 552 units
Where it was sold
- Nationwide
Why it was recalled
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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