COMPREHENSIVE® REVERSE SHOULDER 110040420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304811171), received between Aug 22, 2022 and Aug 22, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (1 report).

1 other recall cover devices cleared under the same FDA submission (K172502); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 22, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE AUGMENT REAMER WAS DULL AND NOT CUTTING PROPERLY. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172502. One submission often covers many models, so check the product and lot details in each record.

• Z-0520-2020 · Aug 21, 2019 · Terminated
  COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331 115330S 115330 110040610 110040620 010000589 CP561861 PM0001456 PM551047 PM551063 PM555137 PM5