Recall Z-0089-2019— Implant Direct Sybron Manufacturing, LLC
Class II · Terminated
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-05-29, terminated 2020-07-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.. Reason: Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-29
- Terminated
- 2020-07-29
- Firm location
- Thousand Oaks, CA, United States
Product description
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Reason for recall
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.