FDA Recall
Terminated
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Recall: Z-1611-2016
·
Initiated February 17, 2016
Recall
- Recall Number
- Z-1611-2016
- Event Number
- 73318
- Firm
- Applied Medical Technology Inc
- FEI Number
- 1526012
- Product Code
- GAD
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- February 17, 2016
- Terminated
- October 27, 2016
- Address
- 8000 Katherine Blvd, Brecksville, OH, 44141-4202
Description
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Reason
The firm received a complaint of an open pouch which breaches the sterilization validation.
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.
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.
Quantity
1,100 units