Nobel Biocare® 36662Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07332747034301), received between Aug 24, 2019 and Aug 24, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (5 reports).

2 FDA recall records name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 9, 2019Class IITerminated

   Packages of abutments 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.

   Z-1852-2020 · Root cause: Process control · Recall details · FDA record ↗

2. Aug 9, 2019Class IITerminated

   Packages of abutments 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.

   Z-1853-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2019Component Misassembled; Component Misassembled

  NOBEL BIOCARE RECEIVED THIS COMPLAINT ON (B)(6) 2019 FROM A CUSTOMER IN (B)(6) STATING THAT AN INCORRECT SCREW WAS PACKED WITH ARTICLE 36662 (TEMPORARY ABUTMENT NON-ENGAGING CC RP), LOT 13078005. THE INCORRECT SCREWS WERE NOT USED ON A PATIENT. INSPECTION OF THE RETAIN AND COMPLAINT SAMPLES CONFIRMED THAT THE BLISTERS CONTAINED HALB 20034 (CATALOG NUMBER 37893) INSTEAD OF THE INTENDED SCREW HALB 12320 (CATALOG NUMBER 37892). MANUFACTURER INVESTIGATION: INVESTIGATION SHOWED THAT ARTICLE 36662 WAS ASSEMBLED WITH HALB 12320 SCREWS FROM BATCH 12122536. IMMEDIATE ACTIONS TAKEN, E.G. QUALITY HOLD/BATCH RESTRICTION INCL. DATE: ARTICLE 36662, LOT 13078005 WAS RESTRICTED ON JUNE 11, 2019. FOLLOWING THE PRELIMINARY INVESTIGATION, LOTS 13077622, 13077550, 13076822, 13077560 AND 13077700 WERE RESTRICTED ON JUNE 27, 2019 AND LOT 13077551 WAS RESTRICTED ON JULY 10, 2019. ROOT CAUSE: THE ROOT CAUSE WILL BE FURTHER INVESTIGATED IN THE CAPA THAT WAS INITIATED (CAPA #(B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928660 ↗
• MalfunctionAug 24, 2019Component Misassembled; Component Misassembled

  NOBEL BIOCARE RECEIVED THIS COMPLAINT ON (B)(6) 2019 FROM A CUSTOMER IN (B)(6) STATING THAT AN INCORRECT SCREW WAS PACKED WITH ARTICLE 36662 (TEMPORARY ABUTMENT NON-ENGAGING CC RP), LOT 13078005. THE INCORRECT SCREWS WERE NOT USED ON A PATIENT. INSPECTION OF THE RETAIN AND COMPLAINT SAMPLES CONFIRMED THAT THE BLISTERS CONTAINED HALB 20034 (CATALOG NUMBER 37893) INSTEAD OF THE INTENDED SCREW HALB 12320 (CATALOG NUMBER 37892). MANUFACTURER INVESTIGATION. INVESTIGATION SHOWED THAT ARTICLE 36662 WAS ASSEMBLED WITH HALB 12320 SCREWS FROM BATCH 12122536. IMMEDIATE ACTIONS TAKEN, E.G. QUALITY HOLD/BATCH RESTRICTION INCL. DATE: ARTICLE 36662, LOT 13078005 WAS RESTRICTED ON (B)(6) 2019. FOLLOWING THE PRELIMINARY INVESTIGATION, LOTS 13077622, 13077550, 13076822, 13077560 AND 13077700 WERE RESTRICTED ON (B)(6) 2019 AND LOT 13077551 WAS RESTRICTED ON (B)(6) 2019. ROOT CAUSE: THE ROOT CAUSE WILL BE FURTHER INVESTIGATED IN THE CAPA THAT WAS INITIATED (CAPA #(B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928659 ↗
• MalfunctionAug 24, 2019Component Misassembled; Component Misassembled

  NOBEL BIOCARE RECEIVED THIS COMPLAINT ON MAY 23, 2019 FROM A CUSTOMER IN (B)(6) STATING THAT AN INCORRECT SCREW WAS PACKED WITH ARTICLE 36662 (TEMPORARY ABUTMENT NON-ENGAGING CC RP), LOT 13078005. THE INCORRECT SCREWS WERE NOT USED ON A PATIENT. INSPECTION OF THE RETAIN AND COMPLAINT SAMPLES CONFIRMED THAT THE BLISTERS CONTAINED HALB 20034 (CATALOG NUMBER 37893) INSTEAD OF THE INTENDED SCREW HALB 12320 (CATALOG NUMBER 37892). MANUFACTURER INVESTIGATION: INVESTIGATION SHOWED THAT ARTICLE 36662 WAS ASSEMBLED WITH HALB 12320 SCREWS FROM BATCH 12122536. IMMEDIATE ACTIONS TAKEN, E.G. QUALITY HOLD/BATCH RESTRICTION INCL. DATE: ARTICLE 36662, LOT 13078005 WAS RESTRICTED ON JUNE 11, 2019. FOLLOWING THE PRELIMINARY INVESTIGATION, LOTS 13077622, 13077550, 13076822, 13077560 AND 13077700 WERE RESTRICTED ON JUNE 27, 2019 AND LOT 13077551 WAS RESTRICTED ON JULY 10, 2019. ROOT CAUSE: THE ROOT CAUSE WILL BE FURTHER INVESTIGATED IN THE CAPA THAT WAS INITIATED (CAPA #(B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928658 ↗
• MalfunctionAug 24, 2019Component Misassembled; Component Misassembled

  NOBEL BIOCARE RECEIVED THIS COMPLAINT ON (B)(6) 2019 FROM A CUSTOMER IN (B)(6) STATING THAT AN INCORRECT SCREW WAS PACKED WITH ARTICLE 36662 (TEMPORARY ABUTMENT NON-ENGAGING CC RP), LOT 13078005. THE INCORRECT SCREWS WERE NOT USED ON A PATIENT. INSPECTION OF THE RETAIN AND COMPLAINT SAMPLES CONFIRMED THAT THE BLISTERS CONTAINED HALB 20034 (CATALOG NUMBER 37893) INSTEAD OF THE INTENDED SCREW HALB 12320 (CATALOG NUMBER 37892). MANUFACTURER INVESTIGATION: INVESTIGATION SHOWED THAT ARTICLE 36662 WAS ASSEMBLED WITH HALB 12320 SCREWS FROM BATCH 12122536. IMMEDIATE ACTIONS TAKEN, E.G. QUALITY HOLD/BATCH RESTRICTION INCL. DATE: ARTICLE 36662, LOT 13078005 WAS RESTRICTED ON JUNE 11, 2019. FOLLOWING THE PRELIMINARY INVESTIGATION, LOTS 13077622, 13077550, 13076822, 13077560 AND 13077700 WERE RESTRICTED ON JUNE 27, 2019 AND LOT 13077551 WAS RESTRICTED ON JULY 10, 2019. ROOT CAUSE THE ROOT CAUSE WILL BE FURTHER INVESTIGATED IN THE CAPA THAT WAS INITIATED (CAPA #(B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928657 ↗
• MalfunctionAug 24, 2019Component Misassembled; Component Misassembled

  NOBEL BIOCARE RECEIVED THIS COMPLAINT ON MAY 23, 2019 FROM A CUSTOMER IN (B)(6) STATING THAT AN INCORRECT SCREW WAS PACKED WITH ARTICLE 36662 (TEMPORARY ABUTMENT NON-ENGAGING CC RP), LOT 13078005. THE INCORRECT SCREWS WERE NOT USED ON A PATIENT. INSPECTION OF THE RETAIN AND COMPLAINT SAMPLES CONFIRMED THAT THE BLISTERS CONTAINED HALB 20034 (CATALOG NUMBER 37893) INSTEAD OF THE INTENDED SCREW HALB 12320 (CATALOG NUMBER 37892). MANUFACTURER INVESTIGATION: INVESTIGATION SHOWED THAT ARTICLE 36662 WAS ASSEMBLED WITH HALB 12320 SCREWS FROM BATCH 12122536. IMMEDIATE ACTIONS TAKEN, E.G. QUALITY HOLD/BATCH RESTRICTION INCL. DATE: ARTICLE 36662, LOT 13078005 WAS RESTRICTED ON JUNE 11, 2019. FOLLOWING THE PRELIMINARY INVESTIGATION, LOTS 13077622, 13077550, 13076822, 13077560 AND 13077700 WERE RESTRICTED ON JUNE 27, 2019 AND LOT 13077551 WAS RESTRICTED ON JULY 10, 2019. ROOT CAUSE THE ROOT CAUSE WILL BE FURTHER INVESTIGATED IN THE CAPA THAT WAS INITIATED (CAPA #(B)(4)).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8928656 ↗