TZ Medical Inc.: Medical Device Recall in 2015 - (Recall #: Z-0318-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 14, 2015

Date Posted: November 25, 2015

Recall Number: Z-0318-2016

Event ID: 72450

Reason for Recall:

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

Status: Terminated

Product Quantity: 10,180 units

Code Information:

Lot Numbers: 2012-0809; 2012-0903; 2012-1011.

Distribution Pattern:

US in the states of AL, AR, CA, DC, FL, GA, IA, MD, NC, NE, NH, PA, RI, SC, TN, TX, UT, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated