Recall Z-0715-2014— The Anspach Effort, Inc.

Name: FDA recall Z-0715-2014
Creator: U.S. Food and Drug Administration
Published: 2012-03-29

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2012-03-29, terminated 2017-10-12. It names one FDA 510(k) clearance: K042783. Product: Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures. Reason: Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-03-29
Terminated: 2017-10-12
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K042783 — ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEMThe Anspach Effort, Inc.·cleared 2004-12-17

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 MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures

Reason for recall

Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.

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