Reported Jan 27, 2016 · Terminated
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY.…
Abeon Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abeon Medical Corporation · 8000 Katherine Blvd · Brecksville, OH · 44141-4202
Is this the product you have?
- 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.
- Lot codes and dates
39 of 39 products
Products covered by this recall Model / number Product as published — Lot # 14121931 Exp Date 2017/12 — Lot # 15010126 Exp Date 2018/01 — Lot # 15013122 Exp Date 2018/01 — Lot # 15013123 Exp Date 2018/01 — Lot # 15021046 Exp Date 2018/01 — Lot # 15021051 Exp Date 2018/01 — Lot # 15024395 Exp Date 2018/02 — Lot # 15031873 Exp Date 2018/03 — Lot # 15033220 Exp Date 2018/02 — Lot # 15040515 Exp Date 2017/06 — Lot # 15044161 Exp Date 2017/12 — Lot # 15044717 Exp Date 2018/04 — Lot # 15050167 Exp Date 2017/12 — Lot # 15051473 Exp Date 2018/05 — Lot # 15051474 Exp Date 2018/05 — Lot # 15062728 Exp Date 2017/12 — Lot # 15070483 Exp Date 2018/01 — Lot # 15070485 Exp Date 2018/01 — Lot # 15074959 Exp Date 2018/07 — Lot # 15075862 Exp Date 2018/01 - Amount recalled
- 575 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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