FDAClass IIApril 25, 2018

Stage-1 Tissue Punch recall

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

Why was Stage-1 Tissue Punch recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and 34987, expiration date: 2022-07.

Product
Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support…
Recalling firm
Keystone Dental Inc
Quantity
101
Distribution
Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
Recall date
April 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls