Recall Z-1629-2014— The Anspach Effort, Inc.

Name: FDA recall Z-1629-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-03

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2013-12-03, terminated 2016-04-18. It names one FDA 510(k) clearance: K030576. Product: Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.. Reason: The Irrigation Clips were assembled with the incorrect (smaller) clips..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-03
Terminated: 2016-04-18
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K030576 — ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP IIThe Anspach Effort, Inc.·cleared 2003-05-21

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 Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.

Reason for recall

The Irrigation Clips were assembled with the incorrect (smaller) clips.

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