Z-1611-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- February 17, 2016
- Termination Date
- October 27, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,100 units
Product Description
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Reason for Recall
The firm received a complaint of an open pouch which breaches the sterilization validation.
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.
Code Information
Part #: TLC5042-M