Agency classClass IIOur severity:High FDA (Devices)·Z-0559-2013·Announced 2012-12-26

Integra Recalls Mayfield Skull Clamps Due to Performance Issues

Integra LifeSciences is recalling eight Mayfield Composite Series Skull Clamps (Model A3059) due to product performance issues that could impact functionality.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in neurosurgery and spinal surgery where performance issues could impact functionality, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Integra LifeSciences Corporation is recalling eight (8) Mayfield Composite Series Skull Clamps, Model A3059 (510(k) #K120633). The recalled products are identified by Lot Numbers 096455 and 097546. These skull clamps are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.

The recall was initiated after an investigation of an adverse trend of complaints identified various product performance issues. These issues could impact the functionality of the Mayfield Composite Series Base Units and Mayfield Skull Clamps. The firm decided to recall and replace certain lot codes to prevent additional complaint reports.

The affected products were distributed nationwide, including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI. Healthcare facilities and users should stop using the affected units and contact the firm for replacement.

The recalled product

Product: MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
Manufacturer: Integra LifeSciences Corporation
Category: Medical Device — Surgical Instrument
Hazard: product-performance
functional-failure
Affected units: 8

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 (1)

The recalled product is identified with the Lot Numbers: 096455 and 097546.

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Integra LifeSciences Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Integra LifeSciences Corporation

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