Recall Z-3115-2017— Implant Direct Sybron Manufacturing, LLC
Class II · Terminated
Class II FDA medical device recall by Implant Direct Sybron Manufacturing, LLC, initiated 2017-06-26, terminated 2021-06-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.. Reason: The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require..
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-26
- Terminated
- 2021-06-16
- Firm location
- Westlake Village, CA, United States
Product description
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.
Reason for recall
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Data sourced from openFDA. This site is unofficial and independent of the FDA.