REMOTION WA/R-LMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886385015538), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2018Break; Loose or Intermittent Connection

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) ASSOCIATION. THE REPORT IS ASSOCIATED WITH THE REMOTION SYSTEM, WITHIN THAT REPORT, 3 POST-OPERATIVE COMPLICATIONS/ REVISIONS WERE REPORTED, WHICH OCCURRED IN 2008, 2009 AND 2013. THE REASON FOR REVISION WERE LOOSENING (1 CASE), IMPLANT BREAKAGE WRIST PLATE (1 CASE) AND INFECTION (1 CASE). A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 3 COMPLAINTS WERE INITIATED RETROSPECTIVELY. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO LOOSENING.

  Patient problems: Unspecified Infection

  MAUDE report 7803357 ↗