FDA-Device2014-01-22Class II
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
The Anspach Effort, Inc.
Hazard
Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.
Sold states
Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.
Affected count
1,805,022 cutting burs and 55,026 irrigation clips
Manufactured in
4500 Riverside Dr, Palm Beach Gardens, FL, United States
Products
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2014Don't want to check this manually?
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