Recall Z-0548-2021— Integra LifeSciences Corp.

Name: FDA recall Z-0548-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-11

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2020-11-11, terminated 2021-06-17. It names one FDA 510(k) clearance: K932807. Product: Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000. Reason: Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram.

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2020-11-11
Terminated: 2021-06-17
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K932807 — MAYFIELD* A-2000 SKULL CLAMPOhio Medical Instrument Co., Inc.·cleared 1993-09-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000

Reason for recall

Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

Data sourced from openFDA. This site is unofficial and independent of the FDA.