Recall Z-0923-2013— Keystone Dental Inc
Class II · Terminated
Class II FDA medical device recall by Keystone Dental Inc, initiated 2011-07-05, terminated 2013-03-11. It names one FDA 510(k) clearance: K101545. Product: Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.. Reason: Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,.
- Recalling firm
- Keystone Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-07-05
- Terminated
- 2013-03-11
- Firm location
- Burlington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Reason for recall
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Data sourced from openFDA. This site is unofficial and independent of the FDA.