Z-2077-2012Class II

.ANSPACHSterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD...

Name: Z-2077-2012 .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD...
Creator: The Anspach Effort, Inc.
Published: 2011-09-19
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2011-09-19 / Terminated / root cause: design

FDA source

The Anspach Effort, Inc. began a recall of .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and... on 2011-09-19. FDA classified it as Class II and gives the reason as "Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2077-2012
Classification: Class II
Status: Terminated
Initiated: 2011-09-19
Posted: 2012-07-25
Terminated: 2013-07-25
Recalling firm: The Anspach Effort, Inc.
Product: .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Product code: HTW Bit, Drill
Reason for recall: Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated December 15, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the batches listed in the letter. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply form indicating if the item(s) are being returned and confiming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
Quantity in commerce: 5 each
Distribution: US Nationwide Distribution including the states of: Arizona. and California.
Product codes and lots: Lot numbers E203050779 and E383055709.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2077-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2077-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-25

Product code HTW

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)