Nobel Biocare Dense Bone Drill Recall Due to Sterility Concerns
Nobel Biocare is recalling Dense Bone Drills because a packaging sealing issue may compromise sterility during shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling Dense Bone Drill NP 3.5x16 mm Single-Pat devices. These drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
The recall is due to a problem in the packaging sealing process at the supplier of the affected devices. As a result, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
The affected devices were distributed worldwide, including US Nationwide distribution and various countries such as CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, and SE. The specific catalog number for the affected units is 37095.
The recalled product
- Product
- Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
- Manufacturer
- Nobel Biocare Usa Llc
- Hazard
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)
- (01)07332747065480(10)73574 Catalog# 37095
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Nobel Biocare Usa Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 24 products in this recall →Related recalls
Same manufacturer · Nobel Biocare Usa Llc
See all →- HighNobelReplace dental implant components recalled for driver engagement defect
FDA (Devices) · 2022-03-02
- SevereNobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2020-05-13
- ModerateNobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22