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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72450

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 14, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TZ Medical Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0318-2016
Recall number
Z-0318-2016
Initiated
October 14, 2015
Classification
Class II
Status
Terminated
Recalling firm
TZ Medical Inc.
Quantity
10,180 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

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

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.