TSX ImplantsRecalls & reported problems across all models

We found 28 models of TSX Implants by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 1,279 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2023 and Sep 30, 2026 — classified as 1,195 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (23 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TSX Implants problems

TSX Implants models

28 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TSX Implants TSX47B10

  Implant, Endosseous, Root-Form
  136 reports
• TSX Implants TSX37B11

  Implant, Endosseous, Root-Form
  118 reports
• TSX Implants TSX37B10

  Implant, Endosseous, Root-Form
  107 reports
• TSX Implants TSX41B10

  Implant, Endosseous, Root-Form
  100 reports
• TSX Implants TSX54B10

  Implant, Endosseous, Root-Form
  83 reports
• TSX Implants TSX47B8

  Implant, Endosseous, Root-Form
  74 reports
• TSX Implants TSX37B13

  Implant, Endosseous, Root-Form
  70 reports
• TSX Implants TSX41B11

  Implant, Endosseous, Root-Form
  68 reports
• TSX Implants TSX47B11

  Implant, Endosseous, Root-Form
  66 reports
• TSX Implants TSX6B10

  Implant, Endosseous, Root-Form
  50 reports
• TSX Implants TSX41B13

  Implant, Endosseous, Root-Form
  48 reports
• TSX Implants TSX41B8

  Implant, Endosseous, Root-Form
  45 reports
• TSX Implants TSX37B8

  Implant, Endosseous, Root-Form
  39 reports
• TSX Implants TSX47B13

  Implant, Endosseous, Root-Form
  35 reports
• TSX Implants TSX31B10

  Implant, Endosseous, Root-Form
  32 reports
• TSX Implants TSX31B11

  Implant, Endosseous, Root-Form
  32 reports
• TSX Implants TSX54B8

  Implant, Endosseous, Root-Form
  31 reports
• TSX Implants TSX54B11

  Implant, Endosseous, Root-Form
  30 reports
• TSX Implants TSX37B16

  Implant, Endosseous, Root-Form
  20 reports
• TSX Implants TSX6B11

  Implant, Endosseous, Root-Form
  19 reports
• TSX Implants TSX6B8

  Implant, Endosseous, Root-Form
  16 reports
• TSX Implants TSX54B13

  Implant, Endosseous, Root-Form
  13 reports
• TSX Implants TSX31B13

  Implant, Endosseous, Root-Form
  11 reports
• TSX Implants TSX41B16

  Implant, Endosseous, Root-Form
  10 reports
• TSX Implants TSX31B8

  Implant, Endosseous, Root-Form
  9 reports
• TSX Implants TSX47B16

  Implant, Endosseous, Root-Form
  8 reports
• TSX Implants TSX6B13

  Implant, Endosseous, Root-Form
  6 reports
• TSX Implants TSX31B16

  Implant, Endosseous, Root-Form
  3 reports

Recent TSX Implants adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was observed radiographic bone loss with abcess and the implant was removed due to bone loss and infection.

  Patient problems: Abscess; Osteolysis; Unspecified Infection

  MAUDE report 50945400 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an implant was removed due to a peri-implantitis at tooth site 26.Pain was reported as a consequence.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50914533 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implants at tooth sites #10 and #11 were removed due to peri-implantitis and infection.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50772658 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implants at tooth sites #10 and #11 were removed due to peri-implantitis and infection.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50771252 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #16 was removed due to an infection at the implant site.

  Patient problems: Unspecified Infection

  MAUDE report 50770671 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced numbness for a whole week, and therefore implants #29 and #31 were removed. Doctor reported nerve injury. Paresthesia and edema were also reported.

  Patient problems: Nerve Damage; Numbness; Paresthesia

  MAUDE report 50770627 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #22 was removed due to peri-implantitis. During the uncovering appointment, movement of the implant was noted after placement of the healing abutment, and the implant was subsequently removed.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50770261 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #25 was removed due to peri-implantitis with loss of osseointegration.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50769715 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #16 was removed due to peri-implantitis, with associated bone loss and infection.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50769474 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #23 was removed due to peri-implantitis. The patient presented with pain around the implant and swelling in the area. Clinical and radiographic examination revealed an infection at the implant site.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 50769375 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #26 was removed due to peri-implantitis associated with significant bone loss.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50769120 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #25 was removed due to peri-implantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50769042 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #14 was removed due to peri-implantitis. The patient experienced pain and swelling.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 50768852 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the implant at tooth site #1 was removed due to peri-implantitis.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 50768778 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient returned one month postoperatively following implant placement at tooth site 14 with an indirect sinus lift and presented with symptoms of a sinus infection and persistent drainage. The patient completed a course of antibiotics; however, the symptoms persisted. Sinus rinses were recommended, but the patient returned two weeks later with no improvement. Due to the persistent infection, the implant was removed, the maxillary sinus was cleaned, and a larger-diameter implant was placed.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50754214 ↗

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