BioHorizons Recalls Dental Implants with Incorrect Length Labeling
BioHorizons is recalling 119 units of dental implants labeled as 10.5mm but actually measuring 12mm. The recall addresses a labeling error regarding the product's physical dimensions.
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: This is a Class II recall involving a labeling error regarding product dimensions. While the discrepancy could affect surgical planning, the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
BioHorizons Implant Systems Inc is recalling 119 units of External Implant RBT, D3 Threadform 4.0 X 10.5mm (REF 40105D3). The recall is due to a labeling error where the implants are labeled as 10.5mm in length but are actually 12mm in length.
The affected products are sterile, prescription-only dental implants. The distribution was worldwide, including nationwide distribution in the United States to Louisiana, California, North Carolina, Illinois, Pennsylvania, and New York, as well as international distribution to Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain. The specific lot number is 1302762, with an expiration date of May 31, 2018.
Healthcare providers and consumers should check their inventory for this specific lot number and reference code. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
- Manufacturer
- BioHorizons Implant Systems Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 119
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 (2)
- Lot Number 1302762
- Exp 31 MAY 2018
Distribution
Related recalls
Same manufacturer · BioHorizons Implant Systems Inc
See all →- ModerateBioHorizons Dental Implant Recalled Due to Incorrect Length Labeling
FDA (Devices) · 2015-12-16
- ModerateBioHorizons Recalls Tapered HD Upgrade Set Due to Incorrect Drill Component
FDA (Devices) · 2015-05-20
- HighBioHorizons Recalls Titanium Tack Starter Kits Due to Cleaning Instructions
FDA (Devices) · 2012-12-26
- HighBioHorizons AutoTac Delivery Handle Recalled for Insufficient Cleaning Instructions
FDA (Devices) · 2012-12-26
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- 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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateBioHorizons Dental Implant Recalled Due to Incorrect Length Labeling
FDA (Devices) · 2015-12-16
- SevereNobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
FDA (Devices) · 2020-06-10
- ModerateDental implant system recalled for incorrect package length labeling
FDA (Devices) · 2023-05-24
- ModerateStraumann BLT Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2026-08-19
- ModerateBiomet 3i Dental Implant Recall Due to Outer Box Mislabeling
FDA (Devices) · 2013-08-21
- ModerateSouthern Implants Recalls Dental Implants Due to Labeling Mismatch
FDA (Devices) · 2015-03-18