PECA® 2.0 PS060054Recalls & reported problems
Novastep · Bunion implant Ø4 lg54 · Class 2 · Implant
Data updated Oct 16, 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 03700879516356), received between Mar 23, 2026 and Mar 23, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Malunion of Bone1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
WE HAVE RECEIVED THE INFORMATION THAT A REVISION SURGERY TOOK PLACE ON THE (B)(6) 2026 TO REMOVE THE PECA SCREWS (2 SCREWS) DUE TO PATIENT NONCOMPLIANCE. DATE OF THE FIRST SURGERY IS (B)(6) 2025, WAS COMPLETED SUCCESSFULLY ACCORDING TO THE REPORTED; ALSO THE REVISION SURGERY WAS COMPLITED SUCCESSFULLY AND NO DEFECT WAS OBSERVED ON THE EXPLANTED DEVICES. THE REVISION CONSISTED OF REPLACING THE SCREWS WITH A LISFRANC PLATE SYSTEM. NO FURTHER INFORMATIONS HAVE BEEN COMMUNICATED. TWO SCREWS ARE MENTIONED IN THIS REPORT. SINCE SECTION D ALLOWS ONLY ONE REFERENCE TO BE ENTERED, THE FULL DETAILS OF THE PRODUCTS ASSOCIATED WITH THIS EVENT ARE PROVIDED BELOW : (B)(4): PRODUCT REFRENCE. BUNION IMPLANT Ø4 LG54 : PRODUCT NAME. (B)(4) : UDI-DI. M24865 : BATCH NUMBER. EXPIRY DATE : 04/01/2030. (B)(4): PRODUCT REFRENCE. BUNION IMPLANT Ø4 LG42: PRODUCT NAME. 03700879516295:UDI-DI. M24857 : BATCH NUMBER. EXPIRY DATE: 04/01/2030.
Patient problems: Malunion of Bone
MAUDE report 24663283 ↗
Other Screw, Fixation, Bone devices
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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