Lower risk Medical device recall · FDA · Published December 17, 2021

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707: Risk of surgical delays due

Nobel Biocare recalls specific NobelReplace Conical Connection implants due to potential incorrect offset gauge during production, which may cause surgical delays or aborted procedures. Affected units have unique identifiers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0658-2022Medical device Nobel Biocare ›

Lower-risk 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.

Take action

Contact the company

Recalling firmNobel Biocare Usa Llc22715 Savi Ranch Pkwy · Yorba Linda, CA 92887-4609

✎ GovInfoNow plain-language explainer

Nobel Biocare is recalling certain NobelReplace Conical Connection implants because they might have been made with the wrong offset gauge, which could lead to surgical delays or procedures being aborted. This recall affects specific model numbers and lot numbers. Read more at govinfonow.com/recall/61421-nobelreplace-conical-connection-rp-4-3x11-5-mm-ref-36707.

Source Summary by GovInfoNow · govinfonow.com/recall/61421-nobelreplace-conical-connection-rp-4-3x11-5-mm-ref-36707 · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0658-2022

Cite this page

“NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707: Risk of surgical delays due.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61421-nobelreplace-conical-connection-rp-4-3x11-5-mm-ref-36707. Based on FDA recall #Z-0658-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0658-2022%22&limit=1).

The FDA announced on Dec. 17, 2021, that Nobel Biocare Usa Llc is recalling NobelReplace Conical Connection RP implants due to potential surgical delays. The agency said the recall was voluntary and initiated by the firm.

How to tell if you have it

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
UPC: 07332747160529
Lot Numbers: 13116495, 13116496, 13116497

The hazard

Nobel Biocare said 16 complaints involved drivers not engaging in implants because an incorrect offset gauge may have been used during production. The firm stated this error could lead to aborted or delayed surgical procedures.

Context

GovInfoNow's records show Nobel Biocare Usa Llc has had six other recalls on record since March 16, 2018. Other recent recalls of similar products include NobelActive Dental Implant Recall (July 19, 2019), Nobel Biocare Temporary Abutment Screws May Loosen - Recall (Aug. 9, 2019), and Nobel Biocare Dental Implant Recall: Incorrect Length Labeling Risk (Aug. 28, 2019). Other recent recalls of similar products include ConMed Suture Anchor Recall (July 14, 2026), U2 Total Knee System Femoral Offset Bushing Recall (March 19, 2026), and Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025).

How to tell if you have this one

Check for the model number 'NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707' and lot numbers 13116495, 13116496, or 13116497. The product has a unique identifier code starting with (01)07332747160529.

Brand
Nobel Biocare
Product
NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number and lot numbers listed in the recall notice to confirm if your implant is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

Dec 17, 2021Firm started the recall
Feb 18, 2022FDA classified it Class II
Mar 2, 2022Published in FDA’s Enforcement Report
Oct 25, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/61421-nobelreplace-conical-connection-rp-4-3x11-5-mm-ref-36707">NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707: Risk of surgical delays due (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0658-2022 (December 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0658-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.