—#52562

Product

Anspach Single Use, Sterile Bone Cutting Burrs

FDA product code: HBB — Motor, Drill, Pneumatic
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K011444, K061297, K955084, K965080
Affected lot / code info: All cutting burrs packaged with an expiration date between June 2008 and august 2011.

Why it was recalled

The white film portion of the sterile pouch may become brittle prior to the expiry date compromising the sterility of the product.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

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.

Timeline

Recall initiated: 2007-05-18
Posted by FDA: 2007-07-11
Terminated: 2009-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52562. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.