Integra LifeSciences Recalls Mayfield Skull Clamps Due to Locking Issues
Integra LifeSciences is recalling 37 Mayfield Skull Clamps because the locking knob may not unlock easily or the torque knob may malfunction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no patient injuries, adverse health consequences, or surgical delays were reported, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 37 units of the Composite Series Skull Clamp (A3059). The recall was initiated after an investigation into an adverse trend of complaints regarding the Skull Clamp index locking knob not easily unlocking or disengaging, as well as malfunctions of the 80 lbs. torque knob.
The affected devices are cranial stabilization devices designed to provide rigid skeletal fixation for open and percutaneous craniotomies and spinal surgery. The recall covers specific serial numbers distributed in the United States, including Alabama, Arkansas, California, Connecticut, Florida, Georgia, Iowa, Illinois, Mississippi, New York, Ohio, South Carolina, Tennessee, and Texas.
According to the source text, none of the complaints resulted in a report of patient injury, adverse health consequence, or a delay or prolongation of the surgical procedure. Consumers and healthcare facilities should check their inventory for the affected serial numbers and contact the manufacturer for instructions on how to return or replace the devices.
The recalled product
- Product
- 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…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 37
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- The following serial numbers are affected by this recall: SS120076
- SS120082
- SS120083
- SS120084
- SS120088
- SS120089
- SS120090
- SS120092
- SS120093
- SS120094
- SS120095
- SS120111
- SS120112
- SS120113
- SS120114
- SS120115
- SS120116
- SS120117
- SS120118
- SS120119
Distribution
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