ENDOBUTTON 72200149Recalls & reported problems
Smith & Nephew, Inc. · ENDOBUTTON CL ULTRA 30MM · Class 2 · Implant
All models of ENDOBUTTON (21)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010597281), received between Jan 10, 2020 and Nov 22, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING ENDOBUTTON DEVICES. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15848431 ↗MalfunctionJan 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER A DISLOCATION OF THE RIGHT ACROMIOCLAVICULAR USING AN ENDOBUTTON, THE WOUND WAS FOUND OOZING AND NOT HEALING. THE PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: Unspecified Infection
MAUDE report 9574481 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE devices
- FAST-FIX 72202468Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 death6,626 reports
- FAST-FIX 72201491Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE863 reports
- FAST-FIX 72202469Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE561 reports
- FAST-FIX 72205676Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE439 reports
- Arthrex® AR-4501Arthrex, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE403 reports
- FAST-FIX 72205324Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE383 reports
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- FAST-FIX 72201494Smith & Nephew, Inc. · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE249 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page