RegWardenFDA facility compliance records
Facility

NOBEL BIOCARE USA, LLC

14 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2015: 2 recalls; 2016: 2 recalls; 2018: 1 recalls; 2019: 5 recalls; 2020: 1 recalls; 2021: 2 recalls1’13’142’152’16’171’185’191’202’21’22’23’24’25’26
  • Recalls (14)

Devices registered here (1)

Recalls & enforcement

20212 records
  • Class IITerminated2021-12-17
    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.
  • Class IITerminated2021-03-29
    Not manufactured to specification
20201 record
  • Class IITerminated2020-07-20
    Dental implant cap label may incorrectly indicate implant measurements 5.0x8mm. Actual implant measurements are 4.3x10mm. If not noticed prior to implant placement, this could lead to: 1) A second surgical procedure; 2) Implant replacement; 3) If placed in posterior lower jaw, th…
20195 records
  • Class IITerminated2019-08-28
    The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
  • Class IITerminated2019-08-09
    Packages of abutments (universal base) 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.
  • Class IITerminated2019-07-19
    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…
  • Class IITerminated2019-05-28
    Packaged dental implant healing abutments were found to contain the wrong size device.
  • Class IITerminated2019-03-14
    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.
20181 record
  • Class IITerminated2018-03-16
    The product label has missing information, such as the lot number and expiration date, as well as other information.
20162 records
20152 records
  • Class IITerminated2015-06-22
    One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
  • Class IITerminated2015-03-09
    A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
20131 record
  • Class IITerminated2013-10-24
    The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NOBEL BIOCARE USA, LLC (FEI 1000125598) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000125598-nobel-biocare-usa-llc/

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