Recall Z-0718-2014— The Anspach Effort, Inc.
Class II · Terminated
Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2011-09-09, terminated 2016-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only. Reason: 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..
- Recalling firm
- The Anspach Effort, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-09-09
- Terminated
- 2016-04-15
- Firm location
- Palm Beach Gardens, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.