FDAJune 26, 2017device
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 cons...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.
What to do
FDA enforcement status: Terminated
Brands named
implant direct sybron manufacturingimplantimplant direct
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDADULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.2026-06-22
- CPSCKawasaki Motors USA Recalls Model Year 2026 Teryx4 H2 and Teryx5 H2 Recreational Off-Road Vehicles Due to Impact and Injury Hazards2026-06-11
- CPSCPressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct2026-04-16
- FDABrand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Model/Catalog Number: DIB00 Software Version: N/A Product Description: The TECNIS SIMPLICITY" Delivery System is designed to provide a sterile,controlled...2026-02-19
- FDAHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd2026-02-18
- CPSCFortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails2026-02-12
- CPSCWatkins Manufacturing Recalls Hydromassage Rotary Jets in Highlife Collection Spas Due to Entanglement and Drowning Hazards2026-02-12
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