Class II — TZ Medical Inc.
| Recalling firm | TZ MEDICAL, INC. |
|---|---|
| Registered facility | TZ MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k |
| Product | SilverStat, sterile 2" x 2 " calcium alginate hemostasis pad with sliver nitrate, Part number 8870-07. Product Usage: SilverStat is an effective barrier to microbial penetration for moderate to heavy exudating partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor and graft sites, traumatic and surgical wounds and 1st and 2nd degree bums. SilverStat is indicated for external use only. |
| Quantity | 10,180 units |
| Distribution | US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV. |
| Initiated | 2015-10-14 |
| Classified | 2015-11-18 |
| Terminated | 2016-10-24 |
| Recall number | Z-0318-2016 |
| 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 — TZ Medical Inc. (Z-0318-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72450/
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