Reported Nov 20, 2013 · Terminated
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device,…
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?
- Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to provide rigid skeletal fixation. The Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid skeletal fixation is necessary
- Lot codes and dates
- The following serial
- numbers are affected by this recall
SS120076SS120082SS120083SS120084SS120088SS120089SS120090SS120092SS120093SS120094SS120095SS120111SS120112SS120113SS120114SS120115SS120116SS120117SS120118SS120119SS120120SS120121SS120122SS120123SS120124SS120125SS120126SS120127SS120128SS120130SS120131SS120133SS120134SS120135SS120171SS120252SS120256SS120257
- Amount recalled
- 37 units
Where it was sold
Why it was recalled
An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.
This product could cause temporary or reversible health problems — stop using it.
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