Wilson Implantation System Product Usage: Indicated to recall
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Why was Wilson Implantation System Product Usage: Indicated to recalled?
The firm received a complaint of an open pouch which breaches the sterilization validation.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part #: TLC5042-M
- Product
- Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
- Recalling firm
- Applied Medical Technology Inc
- Quantity
- 1,100 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.
- Recall date
- May 11, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)