Recall Z-0727-2014— The Anspach Effort, Inc.

Name: FDA recall Z-0727-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-17

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2013-12-17, terminated 2016-05-09. It names one FDA 510(k) clearance: K080802. Product: Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium. Reason: Some carbide cutting burr fractured during use..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-17
Terminated: 2016-05-09
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K080802 — EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDALThe Anspach Effort, Inc.·cleared 2008-04-30

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

Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

Reason for recall

Some carbide cutting burr fractured during use.

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