Recall Z-1443-2018 ยท NDP Accessories, Implant, Dental, Endosseous
Keystone Dental Inc
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.
| Date | Jan 24, 2018 |
| Status | Terminated |
| Reason | The cutting edge of tissue punches may be potentially damaged with small dents and nicks. |
| 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 customersupport@keystonedental.com. |
| Quantity | 101 |
| Distribution | Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.