Class II — Applied Medical Technology Inc
| Recalling firm | APPLIED MEDICAL TECHNOLOGY, INC. |
|---|---|
| Registered facility | APPLIED MEDICAL TECHNOLOGY, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm received a complaint of an open pouch which breaches the sterilization validation. |
| Product | Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure. |
| 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. |
| Initiated | 2016-02-17 |
| Classified | 2016-05-04 |
| Terminated | 2016-10-27 |
| Recall number | Z-1611-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Applied Medical Technology Inc (Z-1611-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73318/
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