centrolock® PL070104Recalls & reported problems
Novastep · 4mm Implant right · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03700879511870), received between Jun 2, 2026 and Jun 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (1 report).
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
- Material Separation1
Patient problems
- Arthralgia1
- Impaired Healing1
- 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.
MalfunctionJun 2, 2026Material Separation
DURING THE FOLLOW-UP X-RAY AT T+6 WEEKS AFTER IMPLANTATION, THE SURGEON OBSERVED THAT THE IMPLANT HAS BROKEN SINCE ITS IMPLANTATION. CASE: TRANSVERSE OSTEOTOMY FOR BUNION CORRECTION. CONSEQUENCE: CORRECTION NOT STABLE - POTENTIAL DELAY FOR RECOVERY, AND POTENTIAL NEED OF AN ADDITIONAL SURGICAL PROCEDURE FOR CORRECTION. THE SURGEON DECIDED TO MAINTAIN THE IMPLANTS IN THE PATIENT AS THE BONE HEALING WAS GOING ON THEN ON (B)(6) 2025: THE SURGEON INFORMED THAT HE PLANNED TO REMOVE THE IMPLANT ON (B)(6) 2026, AND ON (B)(6) 2026: REVISION SURGERY PERFORMED, CENTROLOCK EXPLANTED AND REPLACED BY PECA SCREWS. THE DEVICE WAS RETRIEVED ON APRIL 30TH 2026 AND SHIPPED TO HQ ON MAY 4TH 2026.
Patient problems: Arthralgia; Impaired Healing; Malunion of Bone
MAUDE report 25357998 ↗
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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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