NA 2570-04-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 500 adverse event reports that list this exact device (DI 10603295482024), received between Jun 29, 2018 and May 13, 2026 — classified as 15 injuries, 485 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (381 reports).

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

Recent adverse event reports

The 25 most recent of 500 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT METAL ON THE MODULAR CALCAR PLANER WAS CHIPPING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159526 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT METAL ON THE MODULAR CALCAR PLANER WAS CHIPPING. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159524 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE SMALL PLANERS WERE CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716618 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE SMALL PLANERS WERE CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716328 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE SMALL PLANERS WERE CHIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715799 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT CALCAR PLANER WAS NOT CUTTING. A NEW DEVICE WAS OPENED. SURGICAL DELAY OF A MINUTE .

  Patient problems: Insufficient Information

  MAUDE report 23921035 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE PLANER WAS NOT CUTTING SO A NEW ONE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A ONE (1) MINUTE DELAY AND NO OTHER CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920948 ↗
• MalfunctionDec 4, 2025Break; Failure to Cut; Illegible Information; Break; Failure to Cut; Illegible Information

  IT WAS REPORTED THAT CALCAR PLANER WAS SHEARED AND NO LONGER CUT EVENLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715761 ↗
• MalfunctionDec 3, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT CALCAR PLANAR NOT CUTTING, THEY OPENED A NEW ONE. LOST 1 MIN WHILE OPENING A NEW ONE BUT OTHERWISE NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705053 ↗
• MalfunctionNov 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CALCAR PLANAR WAS NOT CUTTING. OPENED A NEW DEVICE. SURGICAL DELAY WAS 1 MIN. NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632468 ↗
• MalfunctionNov 14, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THE CALCAR PLANER IS DULL AND NOT CUTTING. THE MODULAR SHAFT IS NOT ATTACHING CORRECTLY OR SLIPPING OFF. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553386 ↗
• MalfunctionNov 14, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THE CALCAR PLANER IS DULL AND NOT CUTTING. THE MODULAR SHAFT IS NOT ATTACHING CORRECTLY OR SLIPPING OFF. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553370 ↗
• MalfunctionNov 14, 2025Failure to Cut; Device-Device Incompatibility; Failure to Cut; Device-Device Incompatibility

  IT WAS REPORTED THE CALCAR PLANER IS DULL AND NOT CUTTING. THE MODULAR SHAFT IS NOT ATTACHING CORRECTLY OR SLIPPING OFF. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23553300 ↗
• MalfunctionNov 11, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE PLANAR WAS DULL AND NOT CUTTING, RESULTING IN A ONE-MINUTE DELAY WHILE OPENING A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23524389 ↗
• MalfunctionNov 5, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CALCAR PLANAR WAS NOT CUTTING, SO A NEW ONE WAS OPENED. THERE WAS APPROXIMATELY A 1 MIN DELAY TO THE CASE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476348 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL ON BOTH CASES AND NEEDED TO BE REPLACED. WE GOT THROUGH THE CASE BUT THEY WERE NOT AS SHARP AS THE NEED TO BE. THE CASES WERE COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO DEFICIENCY WITH THE PRODUCT. THE INSTRUMENT BROKE DURING THE CASE AND ALL THE PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. (B)(4) IS LINKED TO (B)(4) CAPTURES THE "INITIAL" CASE MENTIONED IN THE EVENT DESCRIPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475788 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL ON BOTH CASES AND NEEDED TO BE REPLACED. WE GOT THROUGH THE CASE BUT THEY WERE NOT AS SHARP AS THE NEED TO BE. THE CASES WERE COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO DEFICIENCY WITH THE PRODUCT. THE INSTRUMENT BROKE DURING THE CASE AND ALL THE PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. (B)(4) IS LINKED TO (B)(4). (B)(4) CAPTURES THE "INITIAL" CASE MENTIONED IN THE EVENT DESCRIPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475754 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL ON BOTH CASES AND NEEDED TO BE REPLACED. WE GOT THROUGH THE CASE BUT THEY WERE NOT AS SHARP AS THE NEED TO BE. THE CASES WERE COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO DEFICIENCY WITH THE PRODUCT. THE INSTRUMENT BROKE DURING THE CASE AND ALL THE PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. (B)(4) IS LINKED TO (B)(4) CAPTURES THE "INITIAL" CASE MENTIONED IN THE EVENT DESCRIPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475511 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL ON BOTH CASES AND NEEDED TO BE REPLACED. WE GOT THROUGH THE CASE BUT THEY WERE NOT AS SHARP AS THE NEED TO BE. THE CASES WERE COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO DEFICIENCY WITH THE PRODUCT. THE INSTRUMENT BROKE DURING THE CASE AND ALL THE PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. (B)(4) IS LINKED TO (B)(4) CAPTURES THE "OTHER" CASES MENTIONED IN THE EVENT DESCRIPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453665 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL ON BOTH CASES AND NEEDED TO BE REPLACED. WE GOT THROUGH THE CASE BUT THEY WERE NOT AS SHARP AS THE NEED TO BE. THE CASES WERE COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO DEFICIENCY WITH THE PRODUCT. THE INSTRUMENT BROKE DURING THE CASE AND ALL THE PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. (B)(4) IS LINKED TO (B)(4) CAPTURES THE "OTHER" CASES MENTIONED IN THE EVENT DESCRIPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453660 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT THE CALCAR PLANERS WERE DULL ON BOTH CASES AND NEEDED TO BE REPLACED. WE GOT THROUGH THE CASE BUT THEY WERE NOT AS SHARP AS THE NEED TO BE. THE CASES WERE COMPLETED WITHOUT ANY FURTHER ISSUE. THERE WAS NO DEFICIENCY WITH THE PRODUCT. THE INSTRUMENT BROKE DURING THE CASE AND ALL THE PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY. (B)(4) IS LINKED TO (B)(4). (B)(4) CAPTURES THE "OTHER" CASES MENTIONED IN THE EVENT DESCRIPTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453075 ↗
• MalfunctionOct 31, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CALCAR PLANAR WAS NOT CUTTING. A NEW ONE WAS OPENED. THERE WAS A SURGICAL DELAY OF ONE MINUTE DELAY; NO OTHER CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439582 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT THE PART OF THE CALCAR BROKE OFF WHEN USING THE CALCAR PLANER. SURGEON HAS HAD REPEATED PROBLEMS WITH THIS. RELATED COMPLAINT (B)(4) CAPTURES THE ALLEGATION THAT THE SURGEON HAS HAD SIMILAR ISSUES OCCUR IN THE PAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279453 ↗
• MalfunctionSep 12, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE CALCAR PLANAR WAS NOT CUTTING, SO OPENED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23039861 ↗
• MalfunctionSep 11, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT PLANAR WOULDN'T CUT, SO OPENED A NEW ONE THAT WAS PEEL PACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23024486 ↗