Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Reported: January 22, 2014 Initiated: September 9, 2011 #Z-0718-2014
Product Description
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Reason for Recall
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.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 1,805,022 cutting burs and 55,026 irrigation clips
- Distribution
- 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.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only. Recalled by The Anspach Effort, Inc.. Units affected: 1,805,022 cutting burs and 55,026 irrigation clips.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0718-2014.
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