Implant Direct Recalls Spectra Guided Surgery Handle Kits for Dimensional Defects
Implant Direct is recalling 560 Spectra System/Legacy Guided Surgery Handle Kits because some guide inserts do not meet specifications, preventing proper drill passage.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries were reported, and the hazard is a functional defect (dimensional mismatch) rather than a direct safety risk like contamination or structural failure causing injury.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 560 units of the Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) worldwide. The recall involves specific lot numbers including 38665, 38825, 42562, 42649, 43810, 45014, 46950, 50165, 45018, 52360, 52987, 60376, 62435, 64245, 67044, 73431, 73729, 74772, and 70293. The product was distributed in the United States, Europe, Canada, Australia, Egypt, Jordan, and Lebanon.
The recall was initiated because the guided handle inserts were found to be out of Implant Direct specifications. Clinician complaints indicated that the 3.4mm guide insert diameter was too small to allow the 3.4mm drill to pass through, while the 2.3mm guide was too large. This dimensional discrepancy prevents the handle kit from allowing clinicians to drill through the surgical guide with the intended precision and accuracy for implant placement.
Clinicians and distributors should stop using the affected handle kits and contact Implant Direct Sybron Manufacturing, LLC for further instructions on returns or replacements. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as…
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Affected units
- 560
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot # 38665
- 38825
- 42562
- 42649
- 43810
- 45014
- 46950
- 50165
- 45018
- 52360
- 52987
- 60376
- 62435
- 64245
- 67044
- 73431
- 73729
- 74772
- 70293
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Implant Direct Sybron Manufacturing, LLC
See all →- ModerateSterilizable Drill Stop Kits were shipped containing incorrect components
FDA (Devices) · 2025-08-06
- HighDental Implant Abutments Recalled Due to Lack of FDA Clearance
FDA (Devices) · 2023-07-05
- HighDental implant recalled due to size mismatch with labeling
FDA (Devices) · 2021-11-10
- HighDental implants recalled for size mismatch with package labeling
FDA (Devices) · 2021-11-10
- ModerateImplant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws
FDA (Devices) · 2020-02-19
Same hazard · dimensional defect
See all →- HighMedline ENFit G-tube connectors may leak from dimensional specification failure
FDA (Devices) · 2026-04-08
- HighMedline ENFit G-tube connector kits may leak from dimensional defect
FDA (Devices) · 2026-04-08
- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- ModerateMedline Soft Liner Dimensional Variation May Affect Outer Canister Fit
FDA (Devices) · 2024-08-28
- ModerateMedical Device Liner Recalled for Dimensional Variation Affecting Fit
FDA (Devices) · 2024-08-28
Similar recalls
- ModerateImplant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect
FDA (Devices) · 2017-09-20
- ModerateImplant Direct Sybron Recalls GoDirect Dental Implants Due to Tool Error
FDA (Devices) · 2016-04-06
- HighImplant Direct Sybron Recalls DirectGuide Drill Extender for Dental Implants
FDA (Devices) · 2015-12-16
- ModerateImplant Direct Recalls Legacy Full-Contour Abutments for Specification Deviations
FDA (Devices) · 2017-05-31
- ModerateImplant Direct Legacy 3 Implants Recalled for Incorrect Cover Screws
FDA (Devices) · 2020-02-19
- ModerateImplant Direct Dental Implants Recalled for Potential Packaging Error
FDA (Devices) · 2019-11-20