LTXRecalls & reported problems across all models

We found 4 models of LTX by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Dec 1, 2020 and May 27, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

1 FDA recall record name at least one of these models by its device 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. 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

LTX recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Mar 8, 2017Class IITerminated

   A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier

   Z-1701-2017 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported LTX problems

LTX models

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

• LTX LTX610

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 recall0 reports
• LTX LTX310

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  4 reports
• LTX LTX311

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report
• LTX LTX410

  IMPLANT, ENDOSSEOUS, ROOT-FORM
  1 report

Recent LTX adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT DENTAL IMPLANTS LOCATED IN UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT HE HAS PERFORMED A BONE CURETTAGE AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT. THE DOCTOR REPORTED: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 14520339 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTS THAT DENTAL IMPLANTS LOCATED IN UNKNOWN DENTAL POSITIONS FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT HE HAS PERFORMED A BONE CURETTAGE AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH AS A RESULT OF THE EVENT. THE DOCTOR REPORTED: INFLAMMATION.

  Patient problems: Inflammation; Osteolysis; Unspecified Infection

  MAUDE report 14520324 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PERI-IMPLANTITIS WAS DENOTED ON THE IMPLANT SITE. INFLAMMATION WAS REPORTED AS A CONSEQUENCE OF THE EVENT.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12414014 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. MOBILITY WAS REPORTED AS A RESULT OF THE EVENT. TOOTH LOCATION IS UNKNOWN. BONE GRAFT HAS BEEN MADE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12001803 ↗
• InjuryJun 15, 2021Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. MOBILITY WAS REPORTED AS A RESULT OF THE EVENT. TOOTH LOCATION IS UNKNOWN. BONE GRAFT HAS BEEN MADE.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 12001778 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO LACK OF PRIMARY STABILITY. DOCTOR OBSERVED POOR BONE QUALITY ANT THE IMPLANT WAS NOT ABLE TO BE PLACED. NO OTHER IMPLANT WAS PLACED DURING THE SAME SURGERY. ANOTHER IMPLANT WOULD PROBABLY BE PLACED ON 6 MONTHS, AFTER HEALING PERIOD.

  Patient problems: No Code Available

  MAUDE report 10927374 ↗

Other ZimVie US Corp LLC products

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