Reported May 11, 2016 · Terminated
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY…
Applied Medical Technology Inc.
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: Applied Medical Technology Inc · 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 (USA) STERILE
- EO Do Not Resterilize Product UsageIndicated to aid in tissue retraction during a surgical procedure
- Lot codes and dates
- Part #: TLC5042 & TLC5042-I
- Amount recalled
- 2,263 Units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
The firm received a complaint of an open pouch which breaches the sterilization validation.
This product could cause temporary or reversible health problems — stop using it.
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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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