Device product
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Z-1611-2016
Product summary
- Event
- Event 73318
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,100 units
- Official record key
device-enforcement:Z-1611-2016
Official wording
Reason: The firm received a complaint of an open pouch which breaches the sterilization validation.
Code information: Part #: TLC5042-M
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.
Derived failure modes
-
Labeling or packaging
open pouch