Implant Direct Recalls GoDirect Screw-Retaining Top Due to Labeling Error
Implant Direct Sybron Manufacturing is recalling 14 units of GoDirect Screw-Retaining Top (Part No. 4500-61) because they were shipped with incorrect labels for a different product.
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 and involves a labeling error. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as Moderate (Score 2).
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 14 units of the GoDirect Screw-Retaining Top, Part Number 4500-61. The recall is due to a labeling error where the product was shipped with the label for a different item, the 6060-62 Replant Overdenture Abutment.
The affected units are from Lot #75808. The product was distributed in the United States to Washington and internationally to the Netherlands.
Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions on how to return the items.
The recalled product
- Product
- GoDirect Screw-Retaining Top Part Numbers: 4500-61
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 14
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 (1)
- Lot #75808
Distribution
Distribution scope not specified by the agency.
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 · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateImplant Direct Sybron Recalls GoDirect Dental Implants Due to Tool Error
FDA (Devices) · 2016-04-06
- LowImplantDirect Dental Implants Recalled for Incorrect Vial Label Part Number
FDA (Devices) · 2018-08-01
- ModerateImplant Direct Recalls RePlant Angled Abutments Due to Design Defect
FDA (Devices) · 2016-08-10
- ModerateImplant Direct RePlant Dental Implants Recalled for Incorrect Packaging
FDA (Devices) · 2019-10-09
- ModerateImplant Direct Sybron Recalls Out-of-Specification Dental Abutments
FDA (Devices) · 2018-07-11
- HighImplant Direct Recalls SwishTapered Implants Due to Packaging Error
FDA (Devices) · 2017-02-08