Recall record at a glance
| Official record | Z-0718-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | The Anspach Effort, Inc. |
| Report date | Jan 22, 2014 |
| Recall initiation date | Sep 9, 2011 |
| Quantity | 1,805,022 cutting burs and 55,026 irrigation clips |
| Location | Palm Beach Gardens, FL, United States |
Official product description
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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