Nobel Biocare® 33452Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07332747002881), received between May 23, 2019 and May 23, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Inaccurate Information” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON (B)(6) 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEMENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636046 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON (B)(6) 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBEL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON (B)(6) 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEMENT C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636044 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON (B)(6) 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBEL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON (B)(6) 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEMENT C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636043 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON APRIL 23, 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: · THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. · A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636041 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON APRIL 23, 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN. THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636040 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON (B)(6) 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON (B)(6) 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEMENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636038 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON APRIL 23, 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT. A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636036 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON APRIL 23, 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLEM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636034 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON (B)(6) 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: · THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. · A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636031 ↗
• MalfunctionMay 23, 2019Inaccurate Information; Inaccurate Information

  ON (B)(6) 2019 A CUSTOMER IN THE US RETURNED 10 PRODUCTS LABELED 36644 (HEALING ABUTMENT CC RP Ø3.6X5MM), LOT 13076845, STATING THE PACKAGES CONTAIN AN INCORRECT HEALING ABUTMENT. INSPECTION PERFORMED BY NOBEL BIOCARE CONFIRMED THAT ALL TEN PACKAGES CONTAIN ARTICLE 33452 (HEALING ABUTMENT NOBRPL RP Ø5.3X5MM), LOT 13076868. INVESTIGATION CONCLUDED THAT 16 PIECES OF ARTICLE 33452, LOT 13076868 HAD BEEN INCORRECTLY LABELED AS ARTICLE 36644, LOT 13076845. AN EXTRA LABEL SHEET (INCLUDING 16 INDIVIDUAL LABELS) HAD BEEN PRINTED FOR COMPLAINED LOT 13076845. INSTEAD OF THE SHEET BEING SCRAPPED, IT WAS IN ERROR USED ON ARTICLE 33452, LOT 13076868. A HEALTH HAZARD EVALUATION WAS PERFORMED CONCLUDING ON A HIGH RISK FOR THE PATIENT: A MISFIT BETWEEN THE ABUTMENT AND THE IMPLANT COULD POTENTIALLY LEAD TO INFLAMMATION OR DAMAGE TO THE IMPLANT DUE TO INCREASED FORCES ON THE IMPLANT THREADS. BOTH ISSUES COULD RESULT IN A NEED FOR REVISION SURGERY. CORRECTIVE OR REMOVAL ACTIONS THAT HAVE BEEN, AND ARE EXPECTED TO BE TAKEN: THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED: · THE AFFECTED LOT 13076845 WAS RESTRICTED ON MAY 01, 2019. · A CAPA WAS INITIATED TO FURTHER INVESTIGATE THE ISSUE AND TO IMPLE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8636029 ↗