Z-1377-2013Class II

REF S-3D 3mm Diamond Ball. Used for cutting and shaping bone

Name: Z-1377-2013 ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone
Creator: The Anspach Effort, Inc.
Published: 2011-03-04
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2011-03-04 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone on 2011-03-04. FDA classified it as Class II and gives the reason as "Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr". 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-1377-2013
Classification: Class II
Status: Terminated
Initiated: 2011-03-04
Posted: 2013-05-24
Terminated: 2013-12-17
Recalling firm: The Anspach Effort, Inc.
Product: ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.
Quantity in commerce: 1,827 burrs
Distribution: Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
Product codes and lots: Lots numbers: D433040800, D403040236, D383039472.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1377-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code HBE

K113476Class IIAnspach Dissection ToolsThe Anspach Effort, Inc. / cleared 2011-12-16

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)