Applied Medical Recalls Wilson Penile Implantation System Retractor Frame
Applied Medical Technology Inc is recalling Wilson Penile Implantation System Retractor Frames due to a reported open pouch that breaches sterilization validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a breach of sterilization validation for a surgical device, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Applied Medical Technology Inc is recalling 2,263 units of the Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap. The product is indicated to aid in tissue retraction during surgical procedures and is labeled as single-use, sterile, and prescription-only.
The recall was initiated after the firm received a complaint regarding an open pouch, which breaches the sterilization validation for the device. The affected products are identified by Part Numbers TLC5042 and TLC5042-I.
The recalled products were distributed to hospitals and medical facilities in 28 U.S. states, including Alabama, Arizona, California, and Texas, as well as to several international countries including Austria, Germany, and the United Kingdom. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
- Manufacturer
- Applied Medical Technology Inc
- Affected units
- 2,263
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part #: TLC5042 & TLC5042-I
Distribution
Part of a larger recall action
This product is one of 4 recalled by Applied Medical Technology Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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