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U.S. Department of Health and Human Services

Class 2 Device Recall Wilson Penile Implantation System Retractor Frame,

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  Class 2 Device Recall Wilson Penile Implantation System Retractor Frame, see related information
Date Initiated by Firm February 17, 2016
Create Date May 05, 2016
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-1610-2016
Recall Event ID 73318
Product Classification Retractor - Product Code GAD
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.
Code Information Part #: TLC5042 & TLC5042-I
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8000 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information Contact Mr. Daniel C. Filler
440-262-2526
Manufacturer Reason
for Recall		 The firm received a complaint of an open pouch which breaches the sterilization validation.
FDA Determined
Cause 2		 Packaging
Action AMT sent an Urgent Medical Device Recall letter dated February 17, 2016 to their customers. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Service at 440-717-4000.
Quantity in Commerce 2,263 Units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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