Recall Z-0686-2016— 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: Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.. 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
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
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.