Reported Feb 27, 2013 · Terminated
MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar…
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. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
- Lot codes and dates
- Model #
- A3101 Base Units Serial No's
95 of 95 codes
SB120016SB120017SB120019SB120020SB120021SB120022SB120023SB120024SB120025SB120026SB120027SB120028SB120029SB120030SB120031SB120032SB120134SB120036SB120037SB120038SB120040SB120042SB120043SB120044SB120045SB120049SB120050SB120051SB120052SB120053SB120054SB120055SB120056SB120057SB120058SB120059SB120060SB120061SB120062SB120063SB120064SB120065SB120066SB120067SB120068SB120069SB120070SB120071SB120072SB120073SB120074SB120075SB120076SB120077SB120078SB120079SB120080SB120081SB120082SB120083
- Amount recalled
- 96 units
Where it was sold
Why it was recalled
Integra determined there is a possibility that the Base Units may break during use.
This product could cause temporary or reversible health problems — stop using it.
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