FDA Medical Device Recalls (openFDA)
Nobel Biocare Usa Llc: NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
- Recall number
- Z-2207-2020
- Recalling firm
- Nobel Biocare Usa Llc
- Product
- NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
- Status
- Terminated
- Initiated
- 2019-07-19
- Posted
- not on file
- Terminated
- 2020-10-27
- Reason
- The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.
- Root cause
- Labeling mix-ups
- Action
- Customers who received product/affected lot were to be contacted via Urgent Medical Device Recall Letter dated July 18, 2019 via USPS on July 19, 2019. In addition to informing customers about the recall, the recall notification asked customer to take the following actions: 1. Identify affected devices in your stock by confirming the information on the side label: NobelActive Internal NP 3.5x15mm, article 34128, lot 13080792. 2. Confirm the information on the top label as shown in figure 1 above. 3. Complete attached Customer Acknowledgment Form and return it to Nobel Biocare, via email to us.complaints@nobelbiocare.com or fax 714-282-5073, within 5 days of receipt of this letter. 4. Return incorrectly labeled products (top label 3.5x11.5) to: Nobel Biocare Attn: Returns PFA1917 22715 Savi Ranch Pkwy Yorba Linda, CA 92887 . 5. Correctly labeled products (top label 3.5x15) do not need to be returned. 6. If you require any further information or support, please contact your customer support representative at 1-800-322- 5001 x.1527.
- Quantity
- 221 implants
- Distribution
- US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None
- Lot, serial or model codes
- Lot number: 13080792
- 510(k) numbers
- ["K071370"]
- PMA numbers
- not on file
- Product code
- NHA
- Firm FEI
- 1000125598
- Firm city
- Yorba Linda
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28