Recall Z-2125-2017— Implant Direct Sybron Manufacturing, LLC
Class II · Terminated
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2017-05-02, terminated 2018-01-08. It names one FDA 510(k) clearance: K061319. Product: Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD. Reason: Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-02
- Terminated
- 2018-01-08
- Firm location
- Westlake Village, CA, 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
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Reason for recall
Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.