CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
Esthetic Abutment CC RP pre-manufactured prosthetic recalled
Nobel Biocare Usa is recalling Esthetic Abutment CC RP pre-manufactured prosthetic components directly connected to the, distributed nationwide in the US. The recall was initiated on 9 Aug 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-1854-2020
- FDA event ID
- 85159
- Recalling firm
- Nobel Biocare Usa, Yorba Linda, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Aug 2019
- FDA classified
- 4 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 9 Aug 2019 | Recall initiated by company | |
| 4 May 2020 | Classified by FDA | +269 days |
| 13 May 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36669 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
Nationwide ArkansasArizonaCaliforniaColoradoDelawareFloridaGeorgiaIdahoIllinoisIndianaKansasLouisianaMassachusettsMarylandMaineMichiganMissouriNorth CarolinaNebraskaNew Jersey
Questions about this recall
Why was it recalled?
Packages of abutments may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct screw.
Which lots are affected?
Catalog no. 36669, Lot no. 13077560, UDI: (01)07332747032598(10)13077560
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AZ, AR, CA, CO, FL, GA, IL, IN, ID, KS, LA, MI, MD, ME, MA, MO, NY, NC, NJ, NE, NM, OH, OR, OK, PA, TX, TN, VA, WY, WA and WI. Countries of CA, CH, DE, ES, FR, GB, HU, IT, BR, CO, MX, CN, HK, IN, JP and TW.
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 21 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
5 other products · FDA event 85159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Temporary Abutment Engaging CC RP pre-manufactured recalled | Nobel Biocare Usa | Packaging Defects | Nationwide | |
| CLASS II | Universal Base CC RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Packaging Defects | Nationwide | |
| CLASS II | Temporary Snap Abutment Engaging CC RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Packaging Defects | Nationwide | |
| CLASS II | Temporary Abutment Non-Engaging CC RP pre-manufactured recalled | Nobel Biocare Usa | Packaging Defects | Nationwide | |
| CLASS II | Snappy Abutment 5.5 CC RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Packaging Defects | Nationwide |
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 | Lead & Heavy Metals | 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 | Sterility | 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 Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |