CLASS II Device recall · Reported 2 Mar 2022 · FDA Enforcement Report
NobelReplace Conical Connection RP recalled by Nobel Biocare Usa
Nobel Biocare Usa is recalling NobelReplace Conical Connection RP, distributed nationwide in the US. The recall was initiated on 17 Dec 2021 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-0658-2022
- FDA event ID
- 89465
- Recalling firm
- Nobel Biocare Usa, Yorba Linda, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2021
- FDA classified
- 18 Feb 2022
- Reported
- 2 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 17 Dec 2021 | Recall initiated by company | |
| 18 Feb 2022 | Classified by FDA | +63 days |
| 2 Mar 2022 | Published in enforcement report | +12 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 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Product as listed by the FDA
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyMassachusettsMaineMichiganMinnesotaMississippiNorth CarolinaNew Jersey
Questions about this recall
Why was it recalled?
Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.
Which lots are affected?
Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.
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.
More recalls from Nobel Biocare Usa
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS II | Temporary Snap Abutment Engaging CC RP recalled by Nobel Biocare Usa | Nobel Biocare Usa | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,950| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits labeled as: C-section Pack recalled | Medline Industries | Other | Nationwide |