Z-1008-2007

Anspach Single Use, Sterile Bone Cutting Burrs

Name: Z-1008-2007 Anspach Single Use, Sterile Bone Cutting Burrs
Creator: The Anspach Effort, Inc.
Published: 2007-05-18
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2007-05-18 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of Anspach Single Use, Sterile Bone Cutting Burrs on 2007-05-18. The reason FDA records is "The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product". 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-1008-2007
Status: Terminated
Initiated: 2007-05-18
Posted: 2007-07-11
Terminated: 2009-01-17
Recalling firm: The Anspach Effort, Inc.
Product: Anspach Single Use, Sterile Bone Cutting Burrs
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm issued a recall letter on May 18, 2007, to its consignee, advising them of the recall. Consignees were asked to screen their inventory for the recalled devices and complete an accompanying product replacement form. The firm will replace all returned product within 30 days.
Quantity in commerce: 1,962,123
Distribution: World wide-Distributed throughout the United States and to Puerto Rico, Canada, Mexico, Japan, Lithuania, Cyprus, Austrailia, England, Sweden, Bahamas, Korea, Germany, Switzerland, Malaysia, Iceland, Portugal, Singapore, Poland, Hungary, Thailand, Austria, Israel, Belgium, Egypt, South Africa, Netherlands, India, Syria, Kenya, Italy, Czech Republic, Jamaica, Columbia, Argentina, Honduras, Saudi Arabia, Greece, Finland, Taiwan, Republic of China, Lebanon, Denmark, France, Hong Kong, Philippines, Venezuela, Argintina, and the United Kingdom.
Product codes and lots: All cutting burrs packaged with an expiration date between June 2008 and august 2011.

Product code HBB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)