FDA Device recall Z-1443-2018
Stage-1 Tissue Punch, Disposable, 4.5mm
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Stage-1 Tissue Punch, Disposable, 4.5mm by Keystone Dental, citing the cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1443-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-24 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Keystone Dental |
| Distribution | CA |
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.
Reason
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Identifiers
| code_info | Lot numbers: 33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and 34987, expiration date: 2022-07. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1443-2018%22
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