Recall Z-2287-2015— The Anspach Effort, Inc.

Name: FDA recall Z-2287-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-13

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2015-04-13, terminated 2016-08-25. It names one FDA 510(k) clearance: K113476. Product: ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.. Reason: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-13
Terminated: 2016-08-25
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K113476 — ANSPACH DISSECTION TOOLSThe Anspach Effort, Inc.·cleared 2011-12-16

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 - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.

Reason for recall

G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

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