Z-1983-2014Class II

Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and...

Name: Z-1983-2014 Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and...
Creator: The Anspach Effort, Inc.
Published: 2014-05-08
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2014-05-08 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium on 2014-05-08. FDA classified it as Class II and gives the reason as "Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1983-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-08
Posted: 2014-07-03
Terminated: 2016-01-29
Recalling firm: The Anspach Effort, Inc.
Product: Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Product code: HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Reason for recall: Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Customers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want copies of the revised labeling.
Quantity in commerce: 115,988 units
Distribution: Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada, Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: DFU: 18-0047: Revisions A & B 18-0074: Revision A; and 18-0105: Revisions A. Operating Manuals: 19-0010: Revisions A, and 19-0013: Revisions A, B, & C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1983-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1983-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-09	2014-07-03

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)