Recall Z-1668-2016— The Anspach Effort, Inc.

Name: FDA recall Z-1668-2016
Creator: U.S. Food and Drug Administration
Published: 2016-03-28

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2016-03-28, terminated 2016-12-14. It names one FDA 510(k) clearance: K131053. Product: ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.. Reason: Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-28
Terminated: 2016-12-14
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEMThe Anspach Effort, Inc.·cleared 2013-12-31

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, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

Reason for recall

Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.

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