Applied Medical Technology Inc: Medical Device Recall in 2016 - (Recall #: Z-1610-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 17, 2016

Date Posted: May 11, 2016

Recall Number: Z-1610-2016

Event ID: 73318

Reason for Recall:

The firm received a complaint of an open pouch which breaches the sterilization validation.

Status: Terminated

Product Quantity: 2,263 Units

Code Information:

Part #: TLC5042 & TLC5042-I

Distribution Pattern:

Product was shipped to the following states: AL, AR, AZ, CA, CT, FL, GA, IA, IN, KS, KY, MA, MD, MI, MN, MO, NC, NE, NH, NJ, OH, PA, SC, TN,TX, UT, VA & WI. Product was also shipped to the following countries: Austria, Denmark, Germany, Italy, Japan, Norway, Spain, Sweden, Switzerland & United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated