SMR Shoulder Connector + ScrewRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390002332), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K110598); 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 16, 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.

• InjuryFeb 12, 2026Unstable

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO INSTABILITY. PATIENT UNDERWENT A REVERSE TOTAL SHOULDER REPLACEMENT ON (B)(6) 2024. DURING ORIGINAL SURGERY FOLLOWING ASSEMBLY WAS IMPLANTED: SMR FINNED STEM SHORT DIA17MM (PN 1304.15.017, LOT 2410458, STERILIZATION (B)(4)), SMR 140° HUMERAL BODY REVERSE (PN 1352.15.011, LOT 2422030, STERILIZATION (B)(4)), SMR REVERSE LINER +3MM (PN 1360.50.815, LOT 24AT30W, STERILIZATION (B)(4)), SMR METAL BACK GLENOID SMALL-R (PN 1375.21.005, LOT 2319076, STERILIZATION (B)(4)), SMR CONNECTOR SMALL-R (PN 1374.15.305, LOT 2300890, STERILIZATION (B)(4)), SMR GLENOSPHERE DIA36MM (PN 1374.09.111, LOT 2325318, STERILIZATION (B)(4)). PATIENT RECENTLY CAME INTO CLINIC REPORTING SHOULDER INSTABILITY. THE SURGEON PERFORMED A REVISION PROCEDURE TO REMOVE THE ABOVE-MENTIONED REVERSE LINER, GLENOSPHERE AND CONNECTOR AND REPLACED THEM WITH A NEW 36MM GLENOSPHERE (PN 1374.09.111) BUT WITH A +4MM LATERALIZED CONNECTOR (PN 1374.15.314) AND A REVERSE LIMAVIT +3 LINER (PN 1360.54.815). ACCORDING TO SURGEON, THE EXTRA 4MM OF LATERALIZATION WILL HELP PATIENT'S STABILITY, AS SHE HAS A LARGE AMOUNT OF ADIPOSE TISSUE ON HER SIDE AND CHEST THAT WAS CAUSING FORCE ON THE CON

  Patient problems: Joint Laxity

  MAUDE report 24322379 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110598. One submission often covers many models, so check the product and lot details in each record.

• Z-1711-2016 · Apr 8, 2016 · Terminated
  SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.