Z-0199-2014Class II

Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including...

Name: Z-0199-2014 Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including...
Creator: The Anspach Effort, Inc.
Published: 2011-05-06
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2011-05-06 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2... on 2011-05-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0199-2014
Classification: Class II
Status: Terminated
Initiated: 2011-05-06
Posted: 2013-11-13
Terminated: 2016-01-28
Recalling firm: The Anspach Effort, Inc.
Product: Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone
Product code: HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The firm, Anspach Effort, Inc., sent an "Urgent Medical Device Labeling Correction" letter dated June 27, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Destroy or delete any items in their inventory immediately and replace with the attached revised Operating Manual, Product Catalog and/or Cutting Bur Chart. 2) Complete and return the attached Customer Reply Form indicating disposition of the labeling materials and confirming their receipt of this letter, and fax to 1-800-327-6661. 3) If they distributed any of the products to other services or facilities, please forward this information as appropriate. For additional copies, contact Anspach Customer Support at (800) 327-6887.
Quantity in commerce: 2,020
Distribution: Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.
Product codes and lots: part number 20-0019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0199-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0198-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-12
Z-0199-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-12
Z-0200-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-12

Product code HSZ

K955084Class IAspach 65,000 (Modification)The Anspach Effort, Inc. / cleared 1996-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)