Recall Z-0829-2014— The Anspach Effort, Inc.

Name: FDA recall Z-0829-2014
Creator: U.S. Food and Drug Administration
Published: 2011-03-31

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2011-03-31, terminated 2019-07-18. It names 2 FDA 510(k) clearances: K011444, K974025. Product: AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.. Reason: Cutter was longer than was stated on the label.

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-03-31
Terminated: 2019-07-18
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K011444 — ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc.·cleared 2001-08-08
K974025 — ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.·cleared 1998-07-06

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

AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

Reason for recall

Cutter was longer than was stated on the label

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