SMR Shoulder Expansion ExtractorRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390097598), received between Jan 7, 2025 and Oct 23, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (K100858); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Break; Break

  DURING A SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, WHEN USING THE SMR - EXPANSION EXTRACTOR (PRODUCT CODE 9013.52.165, LOT #15AA052). WHEN USING THE ER REMOVAL TOOL FOR THE HUMERAL ADAPTOR, THE PEGS WERE NOT STRAIGHT. IT ENDED UP BREAKING OFF AT THE END. SURGICAL TIME EXTENDED BY 20 MINUTES. THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES DUE TO THE ISSUE. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23365752 ↗
• MalfunctionFeb 5, 2025Break; Break

  DURING A SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, WHEN USING THE SMR - EXPANSION EXTRACTOR (PRODUCT CODE 9013.52.165, LOT #15AA052) IN THE HUMERAL BODY, TWO OF THE EXPANSION TINES BROKE. IT WAS REPORTED THAT ONE WAS IMMEDIATELY RECOVERED, THE OTHER WAS NOT NOTICED UNTIL TRYING TO SEAT THE HUMERAL REAMER GUIDE. IT WAS CONFIRMED THAT NO RESIDUAL WAS LEFT IN THE PATIENT. THE STEM EXTRACTOR (PRODUCT CODE 9013.02.301) WAS USED TO COMPLETE THE SURGERY. THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES DUE TO THE ISSUE. THE INSTRUMENT HAS BEEN USED MORE THAN 15 TIMES. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21311499 ↗
• MalfunctionJan 7, 2025Break; Break

  DURING A SHOULDER SURGERY ON (B)(6) 2024, TWO OUT OF THE 4 PRONGS OF THE FOLLOWING INSTRUMENT BROKE OFF: - SMR - EXPANSION EXTRACTOR (PRODUCT CODE 9013.52.165, LOT NUMBER 14AA253) THE SURGERY WAS COMPLETED REMOVING THE ENTIRE STEM CONNECTED TO PROXIMAL BODY. THE INSTRUMENT HAS BEEN USED 5 TIMES APPROXIMATELY. THERE WAS NO EXTENSION OF THE SURGICAL TIME. THE PATIENT IS A MALE, IN ITS 70S. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091029 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100858. One submission often covers many models, so check the product and lot details in each record.

• Z-2540-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
• Z-2539-2015 · Aug 14, 2015 · Terminated
  SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral