Z-1443-2018Class II

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

Name: Z-1443-2018 Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully...
Creator: Keystone Dental Inc
Published: 2018-01-24
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2018-01-24 / Terminated

FDA source

Keystone Dental Inc began a recall of Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of... on 2018-01-24. FDA classified it as Class II and gives the reason as "The cutting edge of tissue punches may be potentially damaged with small dents and nicks". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1443-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-24
Posted: 2018-04-19
Terminated: 2018-07-30
Recalling firm: Keystone Dental Inc.
Product: Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
Product code: NDP Accessories, Implant, Dental, Endosseous
Reason for recall: The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
FDA root cause: Under Investigation by firm
Action: An Urgent - Medical Device Recall letter, dated January 31, 2018, was sent to the impacted customers on 02/01/2018. The letter identified the affected device and the reason for the recall. Customers were instructed to immediately cease using the recalled product and return unused products to Keystone Dental. Customer Relations Reply Forms are being utilized to document the communication. Completed Relations Reply Forms should be faxed/ emailed to Customer Support; 866-903-9272 or [email protected].
Quantity in commerce: 101
Distribution: Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
Product codes and lots: Lot numbers: 33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and 34987, expiration date: 2022-07.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1443-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1443-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-19

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)