Implant Direct Recalls Dental Implants Due to Packaging Error
Implant Direct is recalling 23 dental implants because a QA inspection found a healing collar was packaged instead of the implant.
What this means for you
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 packaging error where a different component was shipped. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 23 units of the Implant Direct Legacy 2 Implant (REF: 833708). The recall was initiated after a quality assurance inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the ordered implant.
The affected products are identified by Lot #135128 with an expiration date of 3/12/20. The distribution pattern includes the United States (IN, VA, MD, TX, WA) and Japan. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected implants and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 23
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 #135128 Exp: 3/12/20
Distribution
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02