Z-1037-2015Class II

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the...

Name: Z-1037-2015 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the...
Creator: The Anspach Effort, Inc.
Published: 2014-12-10
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2014-12-10 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1 on 2014-12-10. FDA classified it as Class II and gives the reason as "Customer complaint indicating the color bands on the MIA16-G1 were not correct". 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-1037-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-10
Posted: 2015-02-02
Terminated: 2016-05-09
Recalling firm: The Anspach Effort, Inc.
Product: 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
Product code: HBC Motor, Drill, Electric
Reason for recall: Customer complaint indicating the color bands on the MIA16-G1 were not correct.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.
Quantity in commerce: 8
Distribution: US Distribution to the states of: NC and CA., and Internationally to Switzerland.
Product codes and lots: Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1037-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1037-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-04

Product code HBC

K133604Class IIAnspach Eg1 High Speed System, G1 AttachmentsThe Anspach Effort, Inc. / cleared 2014-01-10

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)