Z-0779-2014Class II

Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with...

Name: Z-0779-2014 Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with...
Creator: The Anspach Effort, Inc.
Published: 2013-05-06
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2013-05-06 / Terminated / root cause: sterility

FDA source

The Anspach Effort, Inc. began a recall of Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including... on 2013-05-06. FDA classified it as Class II and gives the reason as "Product did not reach expected sterility assurance level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0779-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-06
Posted: 2014-01-16
Terminated: 2016-04-18
Recalling firm: The Anspach Effort, Inc.
Product: Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Reason for recall: Product did not reach expected sterility assurance level
Root cause tag: sterility
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: [email protected]. If you distribute any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: [email protected].
Quantity in commerce: 183
Distribution: Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.
Product codes and lots: ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0779-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0779-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-16

Product code ERL

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)