Reported Apr 25, 2018 · Terminated

Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous…

Keystone Dental Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Keystone Dental Inc · 154 Middlesex Tpke · Burlington, MA · 01803-4403

Is this the product you have?

    • Stage-1 Tissue Punch
    • Disposable
    • 4.5mm
  • catalog numberISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations
Lot codes and dates
  • Lot numbers33434
  • expiration date
    • 2022-04
    • 33945
  • expiration date
    • 2022-05
    • 34294
  • expiration date
    • 2022-06
    • and 34987
  • expiration date2022-07
Amount recalled
101

Where it was sold

Why it was recalled

The cutting edge of tissue punches may be potentially damaged with small dents and nicks.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 30, 2018 · Data as of Sep 19, 4:53 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.