LapiplastyRecalls & reported problems across all models

We found 6 models of Lapiplasty by Treace Medical Concepts, Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Jul 31, 2020 and Aug 5, 2026 — classified as 84 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Lapiplasty problems

Lapiplasty models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Lapiplasty SK19

  Screw, Fixation, Bone
  48 reports
• Lapiplasty SK18

  Screw, Fixation, Bone
  13 reports
• Lapiplasty SK26

  Screw, Fixation, Bone
  12 reports
• Lapiplasty SK20

  Screw, Fixation, Bone
  7 reports
• Lapiplasty SK25

  Screw, Fixation, Bone
  6 reports
• Lapiplasty® SD28

  Screw, Fixation, Bone
  1 report

Recent Lapiplasty adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that after an initial bunion surgery, hardware was removed on (b)(6) 2026 due to hardware irritation. There were no deficiencies or malfunctions alleged/found with any TMC device and no other patient outcomes were reported as a result of this event.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50145383 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO NONUNION AND BROKEN PLATE TINES. TWO TINES (INNER PROXIMAL AND INNER DISTAL) ON THE DORSAL QUAD PLATE WERE BROKEN. THE SURGEON REMOVED THE INNER PROXIMAL TINE, BUT THE INNER DISTAL TINE REMAINS IMPLANTED AS THE SURGEON WAS UNABLE TO REMOVE IT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 25236760 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED AND REPLACED DURING A RECENT REVISION SURGERY DUE TO PAIN, SWELLING, LOOSENED AND BROKEN HARDWARE. THE REVISION SURGERY WAS APPROXIMATELY THREE WEEKS PRIOR TO ON (B)(6) 2026, HOWEVER THE EXACT DATE IS UNKNOWN. THE HARDWARE HAD LOOSENED AND A BROKEN SCREW WAS DISCOVERED VIA RADIOGRAPHIC IMAGE DURING A POST-OP FOLLOW-UP. THE PATIENT REPORTED THAT SHE SUBSEQUENTLY DEVELOPED HAMMER TOES OF THE 2ND, 3RD, AND 4TH TOES, AND EXPERIENCED PAIN WHEN PUTTING ON SHOES AND IF ON THE FOOT FOR MORE THAN AN HOUR. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24743351 ↗
• InjuryFeb 25, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED AND REPLACED DURING A RECENT REVISION SURGERY DUE TO PAIN, SWELLING, LOOSENED AND BROKEN HARDWARE. THE REVISION SURGERY WAS APPROXIMATELY THREE WEEKS PRIOR TO (B)(6) 2026, HOWEVER THE EXACT DATE IS UNKNOWN. THE HARDWARE HAD LOOSENED AND A BROKEN SCREW WAS DISCOVERED VIA RADIOGRAPHIC IMAGE DURING A POST-OP FOLLOW-UP. THE PATIENT REPORTED THAT SHE SUBSEQUENTLY DEVELOPED HAMMER TOES OF THE 2ND, 3RD, AND 4TH TOES, AND EXPERIENCED PAIN WHEN PUTTING ON SHOES AND IF ON THE FOOT FOR MORE THAN AN HOUR. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24450010 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE MOST PROXIMAL SCREW ON THE MEDIAL PLATE WAS REMOVED ON (B)(6) 2025 DUE TO PAIN. RADIOGRAPHIC IMAGING INDICATED THE REMOVED SCREW WAS RESTING IN THE INTERCUNEIFORM JOINT. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 23051956 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO MEDIAL PLATE DISCOMFORT. THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 22806953 ↗
• InjuryJul 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, ALL HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO HARDWARE PROMINENCE AND SOFT TISSUE IRRITATION. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22406885 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NON-UNION WITH BUNION RECURRENCE. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 22191432 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A BROKEN TOE AND THE PATIENT BEING UNSATISFIED WITH THE ORIGINAL CORRECTION. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 21940376 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NON-UNION. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21287621 ↗
• InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO NON-UNION. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED/FOUND WITH ANY TMC DEVICE, AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 21287512 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6)2023, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6)2024 DUE TO NON-UNION. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20701122 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6)2023, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6)2024 DUE TO NON-UNION. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20701118 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2023, ALL HARDWARE WAS REMOVED ON (B)(6) 2024 DUE TO DISCOMFORT PRIMARILY DUE TO THE OVERALL FEELING OF THE HARDWARE, AND A BROKEN SCREW THAT WAS DISCOVERED VIA RADIOGRAPHIC IMAGE FROM A POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 20477617 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2024, ALL HARDWARE WAS REMOVED AND REPLACED IN A REVISION SURGERY ON (B)(6) 2024 DUE TO NON-UNION AT THE TMT. THERE WERE NO DEFICIENCIES OR MALFUNCTIONS ALLEGED/FOUND WITH ANY TMC DEVICE AND NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20377126 ↗

Other Treace Medical Concepts, Inc. products

• Lapiplasty SpeedPlate5 models · 113 reports
• Nanoplasty System3 models · 22 reports · 1 recall