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.
Recall
- Recall Number
- Z-1443-2018
- Event Number
- 79615
- Firm
- Keystone Dental Inc
- FEI Number
- 3005990499
- Product Code
- NDP
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- January 24, 2018
- Terminated
- July 30, 2018
- Address
- 154 Middlesex Tpke, Burlington, MA, 01803-4403
Description
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.
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
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].
Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
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