Z-2911-2011

REF MCA5-07SD, QTY: 10.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized...

Name: Z-2911-2011 ***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized...
Creator: The Anspach Effort, Inc.
Published: 2010-10-13
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2010-10-13 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of ***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH... on 2010-10-13. The reason FDA records is "On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure". 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-2911-2011
Status: Terminated
Initiated: 2010-10-13
Posted: 2011-08-01
Terminated: 2011-11-07
Recalling firm: The Anspach Effort, Inc.
Product: ***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** ***REF MCA7-07SD, QTY: 1***0.7 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacturer***Made in USA***The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** Cutting and Shaping bone including bones of the spine and cranium
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL" letter dated October 20, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customer to screen their inventory for the affected product and not to include any product received after October 18, 2010. Customers are instructed to contact Anspach Customer Support at 800-327-6887 to arrange for return and replacement of product. Customers are to complete and return a Customer Reply Form via fax at 800-327-6661. Questions regarding this notice should be directed to Anspach Customer Support at 800-327-6887. Customer notification began on 10/20/2010 in writing (Fed Ex) with instructions to return the required devices. Anspach utilized their sales representatives to facilitate the product replacement and return activities.
Quantity in commerce: 83
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.
Product codes and lots: MCA5-2SD: D163033602, C523029656, and D093032545. MCA7-2SD: D063031861, D243033598, and D133033340. MCA5-07SD: C523029658 and D123033200. MCA7-07SD: C523029662.

Product code HBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)