eXpress® 139-25-2020-SRecalls & reported problems
Novastep · Compressive staple 25-20-20 · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700879502366), received between Oct 30, 2018 and Oct 30, 2018 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem
ADVERSE EVENT COMMUNICATED BY OUR CUSTOMER : FIRST COMMUNICATION THE (B)(6) 2018: BREAKAGE OF A STAPLE. NO REFERENCE AND NO LOT NUMBER OF THE IMPLANT. SECOND COMMUNICATION THE (B)(6) 2018: PATIENT HAD INITIAL SURGERY TO CORRECT BUNION DEFORMITY. FEW MONTHS LATER, THE PATIENT HAS EXPERIENCED PAIN. AFTER THE XRAY, SURGEON OBSERVED THAT THE FUSION WAS NOT FULLY DONE. THE SURGEON DECIDED TO PROCEED TO THE EXPLANTATION OF THE STAPLE. REFERENCE OF THE STAPLE: 139-25-2020-S; LOT NUMBER: 150022.
Patient problems: Pain
MAUDE report 8018315 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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