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.
FDA Recall Z-1443-2018 · Posted None
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Recalling FirmKeystone Dental Inc
Recall StatusTerminated
Product CodeNDP
Date Initiated2018-01-24
Date Terminated2018-07-30
Product Quantity101
Reason for Recall
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
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].
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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