Recall Z-0684-2016— Abeon Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Abeon Medical Corporation, initiated 2015-11-25, terminated 2016-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.. Reason: The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product..
- Recalling firm
- Abeon Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-25
- Terminated
- 2016-10-27
- Firm location
- Brecksville, OH, United States
Product description
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
Reason for recall
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.