Recall Z-0790-2020— Implant Direct Sybron Manufacturing, LLC
Class II · Completed
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2018-11-28. FDA's recall record names no specific 510(k) clearance for this event. Product: ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.. Reason: The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Completed
- Initiated
- 2018-11-28
- Firm location
- Thousand Oaks, CA, United States
Product description
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason for recall
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.