Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spectra-System/Legacy Guided Surgery Handle Kit Recalled by Implant Direct Sybron Manufacturing, LLC Due to The inside diameter of the 2.3mm small drill...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.
Affected Products
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.
Quantity: 84 units
Why Was This Recalled?
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Implant Direct Sybron Manufacturing, LLC
Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report