CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report
Dense Bone Drill NP Single-Pat recalled by Nobel Biocare Usa
Nobel Biocare Usa is recalling Dense Bone Drill NP Single-Pat, distributed nationwide in the US. The recall was initiated on 14 Mar 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1314-2020
- FDA event ID
- 84450
- Recalling firm
- Nobel Biocare Usa, Yorba Linda, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2019
- FDA classified
- 19 Feb 2020
- Reported
- 26 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Masks, Gloves & PPE
Timeline
| 14 Mar 2019 | Recall initiated by company | |
| 19 Feb 2020 | Classified by FDA | +342 days |
| 26 Feb 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution and countries of 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, SE.
Questions about this recall
Why was it recalled?
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Which lots are affected?
(01)07332747065480(10)73574 Catalog# 37095
Where was it sold?
Worldwide distribution - US Nationwide distribution and countries of 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, SE.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
23 other products · FDA event 84450This product is part of a recall event; the main page for the event is Guided Start Drills/Counterbore NobRpl NP recalled by Nobel Biocare Usa.
More recalls from Nobel Biocare Usa
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | NobelReplace Conical Connection RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Other | Nationwide |
| Device | CLASS II | Healing Abutment Conical Connection RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Packaging Defects | Nationwide |
| Device | CLASS II | NobelActive Internal NP 3.5x15mm Endosseus dental implant recalled | Nobel Biocare Usa | Other | 28 states |
| Device | CLASS II | Snappy Abutment 5.5 CC RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Packaging Defects | Nationwide |
| Device | CLASS II | Temporary Abutment Non-Engaging CC RP pre-manufactured recalled | Nobel Biocare Usa | Packaging Defects | Nationwide |
Other Masks, Gloves & PPE recalls
All 451| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Amplatzer Amulet Left Atrial Appendage Occluder recalled by Abbott | Abbott | Other | Nationwide |
| Device | CLASS II | Opportunity Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Opportunity Flex recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | Performance Pro recalled by American Nitrile Operations | American Nitrile Operations | Device Malfunction | Nationwide |
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |