Recall Z-1443-2018— Keystone Dental Inc
Class II · Terminated
Class II FDA medical device recall by Keystone Dental Inc, initiated 2018-01-24, terminated 2018-07-30. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Keystone Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-24
- Terminated
- 2018-07-30
- Firm location
- Burlington, MA, United States
Product 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.
Reason for recall
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Data sourced from openFDA. This site is unofficial and independent of the FDA.