Terminated

Anspach Single Use, Sterile Bone Cutting Burrs

FDA Recall Z-1008-2007 · Posted 2007-07-11

Recalling FirmThe Anspach Effort, Inc.

Recall StatusTerminated

Product CodeHBB

Date Initiated2007-05-18

Date Terminated2009-01-17

Product Quantity1,962,123

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061297ANSPACH IMRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, Inc. · 2007-01-26 K011444ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc. · 2001-08-08 K965080ANSPACH MICROMAX SYSTEMThe Anspach Effort, Inc. · 1997-01-10 K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc. · 1996-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.