simplyFixed Legacy™ Angled 8045-64-15SKRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307117841), received between May 18, 2018 and Jun 20, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K130572); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2018Unsealed Device Packaging; Unsealed Device Packaging

  PER THE COMPLAINT, PRODUCT RECEIVED OPEN, MISSING PARTS WITH WRITING ON LABEL. THERE IS NO PATIENT IMPACT AS IT WAS DISCOVERED BEFORE USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7623494 ↗
• MalfunctionMay 18, 2018Unsealed Device Packaging; Unsealed Device Packaging

  DOCTOR REPORTS LEGACY DENTISTRY SMART PACKS WERE RECEIVED OPENED AND MISSING PARTS WITH WRITTING ON LABEL. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THIS PART AND LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7528211 ↗
• MalfunctionMay 18, 2018Unsealed Device Packaging; Unsealed Device Packaging

  DOCTOR REPORTS THREE OUT OF SIX ORDERED LEGACY DENTISTRY SMART PACKS WERE RECEIVED OPENED AND MISSING PARTS WITH WRITING ON LABEL. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THIS PART AND LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7528192 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130572. One submission often covers many models, so check the product and lot details in each record.

• Z-0363-2020 · Oct 26, 2018 · Terminated
  Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
• Z-1917-2018 · Mar 14, 2018 · Terminated
  ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Produ
• Z-0539-2018 · Jan 23, 2018 · Terminated
  Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
• Z-2551-2018 · Mar 3, 2017 · Terminated
  ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermedia