Recall Z-0198-2014— The Anspach Effort, Inc.

Name: FDA recall Z-0198-2014
Creator: U.S. Food and Drug Administration
Published: 2011-05-06

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2011-05-06, terminated 2016-01-28. It names one FDA 510(k) clearance: K011444. Product: Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.. Reason: Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th.

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-05-06
Terminated: 2016-01-28
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K011444 — ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc.·cleared 2001-08-08

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

Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

Reason for recall

Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th

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