Nanoplasty SystemRecalls & reported problems across all models
Treace Medical Concepts, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Nanoplasty System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls
- 1
We found 3 models of Nanoplasty System by Treace Medical Concepts, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jul 4, 2024 and Sep 22, 2026 — classified as 20 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Nanoplasty System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 2, 2024Open, Classified
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
Z-2718-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Nanoplasty System problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Loosening of Implant Not Related to Bone-Ingrowth5
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Bone Fracture(s)6
- Pain6
- Fall1
- Skin Inflammation/ Irritation1
- Swelling/ Edema1
- Unspecified Infection1
Nanoplasty System models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nanoplasty System SK57Plate, Fixation, Bone1 recall18 reports
- Nanoplasty System SD29Screw, Fixation, Bone3 reports
- Nanoplasty System 02-00198Plate, Fixation, Bone1 report
Recent Nanoplasty System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pain
MAUDE report 50856501 ↗InjurySep 18, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that after an initial bunion surgery on (b)(6) 2026, a bi-cortical screw was removed on (b)(6) 2026 as it had backed out. Review of radiographic images indicated a post-operative fracture of the medial cortex. No other patient outcomes were reported as a result of this event.
Patient problems: Bone Fracture(s)
MAUDE report 50819118 ↗MalfunctionJun 18, 2026Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, A BROKEN PLATE WAS DISCOVERED VIA RADIOGRAPHIC IMAGING. LOSS OF REDUCTION/CORRECTION FROM THE INITIAL SURGERY WAS ALSO NOTED. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE REMAINS IMPLANTED. ALTHOUGH THERE HAS BEEN NO INJURY REPORTED AND NO INFORMATION HAS BEEN RECEIVED INDICATING THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY TO DATE, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, AN MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25550142 ↗InjuryMar 25, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, ALL HARDWARE WAS REMOVED ON (B)(6) 2026 DUE TO THE BICORTICAL SCREW BACKING OUT AND CALLUS FORMATION AT OSTEOTOMY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689486 ↗InjuryMar 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2026, ALL HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2026 DUE TO THE BICORTICAL SCREW BACKING OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682338 ↗InjuryFeb 17, 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 REVISION SURGERY ON (B)(6) 2026 DUE TO PAIN AND PLANTARFLEXED CAPITAL FRAGMENT. 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: Pain
MAUDE report 24367485 ↗InjuryFeb 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, THE SURGICAL SITE WAS REVISED ON (B)(6) 2026 DUE TO PAIN AND PLANTAR FLEXION/TRANSLATION OF THE CAPITAL FRAGMENT. IT WAS ALSO NOTED THAT THE 10MM SCREW MAY HAVE BACKED OUT SLIGHTLY. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain
MAUDE report 24277559 ↗InjuryJan 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, TWO SCREWS WERE REMOVED ON (B)(6) 2025 DUE TO A SCREW THAT BACKED OUT. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24096038 ↗InjuryDec 19, 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, HARDWARE WAS REMOVED AND REPLACED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO A DISPLACED CAPITAL FRAGMENT AFTER THE PATIENT TRIPPED AND FELL. 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: Fall
MAUDE report 23855790 ↗InjuryDec 18, 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, HARDWARE WAS REMOVED ON (B)(6) 2025 DUE TO THE PATIENT FEELING THE PLATE. THE SURGEON NOTED THE PLATE WAS SITTING DORSALLY. 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839444 ↗InjurySep 8, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, HARDWARE WAS REMOVED IN A REVISION SURGERY ON (B)(6) 2025 DUE TO PAIN AND TWO BROKEN SCREWS. THE TWO BROKEN SCREWS WERE DISCOVERED VIA RADIOGRAPHIC IMAGE DURING A POST-OPERATIVE FOLLOW-UP ON (B)(6) 2025. THE PATIENT'S BONES WERE COMPLETELY FUSED/HEALED. THE DISTAL TIPS OF BOTH BROKEN SCREWS WERE RETAINED AS THE SURGEON WAS UNABLE TO REMOVE THEM. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain
MAUDE report 22994933 ↗InjuryJul 16, 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 ON (B)(6) 2025 DUE TO SWELLING AND POTENTIAL POST-OP ACQUIRED INFECTION. 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: Swelling/ Edema; Unspecified Infection
MAUDE report 22522066 ↗InjuryJul 5, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY ON (B)(6) 2025, ALL HARDWARE WAS REMOVED DURING A REVISION SURGERY ON (B)(6) 2025 DUE TO PAIN, LOSS OF CORRECTION AND A BROKEN SCREW THAT WAS DISCOVERED VIA A RADIOGRAPHIC IMAGE FROM A 3-WEEK POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Pain
MAUDE report 22406886 ↗MalfunctionJun 25, 2025Break; Break
IT WAS REPORTED THAT AFTER AN INITIAL BUNION SURGERY, A BROKEN SCREW WAS DISCOVERED VIA RADIOGRAPHIC IMAGE FROM A POST-OP FOLLOW-UP. NO OTHER PATIENT OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT. ALL HARDWARE CURRENTLY REMAINS IMPLANTED. ALTHOUGH THERE HAS BEEN NO INJURY REPORTED AND THIS MALFUNCTION HAS NOT RESULTED IN A REVISION SURGERY TO DATE, THERE HAVE BEEN SIMILAR EVENTS WHERE THIS MALFUNCTION HAS RESULTED IN A REVISION SURGERY. THEREFORE, A MDR WILL BE FILED TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328311 ↗InjuryJun 24, 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 PATIENT EXPERIENCED LOSS OF CORRECTION AND A BONE FRACTURE. NO DEFICIENCIES OR MALFUNCTIONS WERE ALLEGED WITH ANY TMC DEVICE. ALL HARDWARE CURRENTLY REMAINS IMPLANTED, WITH NO SCHEDULED PLANS TO REVISE OR REMOVE THE HARDWARE REPORTED AT THIS TIME. UPON RECEIPT OF ANY ADDITIONAL INFORMATION, THE FILE WILL BE UPDATED AND REASSESSED AS NEEDED.
Patient problems: Bone Fracture(s)
MAUDE report 22325036 ↗
Other Treace Medical Concepts, Inc. products
All Treace Medical Concepts, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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