SWANSONRecalls & reported problems across all models
Wright Medical Technology, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SWANSON model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 1
We found 12 models of SWANSON by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 17 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2021 and Sep 14, 2026 — classified as 14 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
SWANSON 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.
- Jul 27, 2022Open, Classified
An incorrect sizing label was applied to the carton packaging.
Z-1567-2022 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported SWANSON problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Fracture7
- Break2
- Off-Label Use2
- Degraded1
- Inaccurate Information1
Patient problems
- Loss of Range of Motion5
- No Clinical Signs, Symptoms or Conditions4
- Pain4
- Insufficient Information2
- Arthritis1
- Failure of Implant1
- Fungal Infection1
- Hypersensitivity/Allergic reaction1
SWANSON models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SWANSON 4700020PROSTHESIS, FINGER, POLYMER1 recall0 reports
- SWANSON 4700002PROSTHESIS, FINGER, POLYMER4 reports
- SWANSON G4260102PROSTHESIS, TOE, CONSTRAINED, POLYMER2 reports
- SWANSON G4700003PROSTHESIS, FINGER, POLYMER2 reports
- SWANSON G4700004PROSTHESIS, FINGER, POLYMER2 reports
- SWANSON 4700001PROSTHESIS, FINGER, POLYMER1 report
- SWANSON 4700010PROSTHESIS, FINGER, POLYMER1 report
- SWANSON G4260001PROSTHESIS, TOE, CONSTRAINED, POLYMER1 report
- SWANSON G4260101PROSTHESIS, TOE, CONSTRAINED, POLYMER1 report
- SWANSON G4700006PROSTHESIS, FINGER, POLYMER1 report
- SWANSON 24370001TEMPLATE1 report
- SWANSON 24370006TEMPLATE1 report
Recent SWANSON adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765168 ↗MalfunctionMay 6, 2026Off-Label Use
AS REPORTED: "INFORMED THAT THE SURGEON MAY HAVE IMPLANTED A TRIAL IMPLANT FROM SWANSON TENDON ROD CONSIGNMENT TRAY FOR A FIRST STAGE RECONSTRUCTION. STRYKER REP NOT PRESENT AT CASE. NOTIFIED OF INCIDENT ON (B)(6), 2026 AT 4PM. DIRECTED NURSE TO NOTIFY SURGEON OF FINDINGS. HOSPITAL NOTIFIED ME THE FOLLOWING MORNING (B)(6), 2026 THAT THE SURGEON HAD BEEN MADE AWARE THAT EVENING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25101723 ↗InjuryFeb 13, 2026Fracture
IT WAS REPORTED THAT "ON REMOVAL IT WAS NOTICED THAT THE DEVICE WAS BROKEN. IT WAS TORN DOWN ONE SIDE.PATIENT EXPERIENCED SEVERE PAIN IN THE JOINT, REQUIRING HIGH DOSES OF ANALGESIA, INTENSE PHYSIO AND A DIAGNOSIS OF COMPLEX REGIONAL PAIN SYNDROME (CRPS). JOINT SWELLING CONSTANTLY AND PATIENT WAS IN CONSTANT PAIN. BECAUSE OF SEVERE PAIN, PATIENT WAS INVESTIGATED FOR OSTEOMYELITIS. THIS DEFECT WAS NOT PICKED UP ON MAGNETIC RESONANCE IMAGING (MRI) OR X-RAYS."
Patient problems: Pain; Swelling/ Edema
MAUDE report 24333114 ↗MalfunctionJan 16, 2026Fracture
IT WAS REPORTED THAT THE PHYSICIAN HAD IMPLANTED A SIZE 2 SWANSON FLEXIBLE FINGER IMPLANT. THE IMPLANT BROKE A DAY AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24094986 ↗InjuryDec 8, 2025Fracture; Fracture
IT WAS REPORTED THAT A WRIGHT MEDICAL FINGER JOINT IMPLANT FRACTURED. PER INTAKE DISCUSSION, THE PATIENT IS SCHEDULED FOR A FOLLOW-UP SURGERY TO ADDRESS THE IMPLANT FAILURE.
Patient problems: Insufficient Information
MAUDE report 23751088 ↗InjuryAug 14, 2025Break; Fracture; Break; Fracture
SWANSON FLEXSPAN FINGER JOINT IMPLANT BROKE. ORIGINAL SURGERY WENT WELL. PATIENT WAS DOING WELL POSTOP, GOING TO PHYSICAL THERAPY, NO TRAUMA OR ACCIDENT HAPPENED TO RELATED FINGER. PATIENT STARTED HAVING PAIN, HAD A FOLLOW UP X-RAY AND THE BROKEN IMPLANT WAS SEEN ON X-RAY.
Patient problems: Pain
MAUDE report 22805328 ↗InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE IMPLANT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19746597 ↗InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A SWANSON MCP PIP IMPLANTED IN THEIR FINGER. A FEW MONTHS LATER IT WAS REPORTED THAT THE PATIENT HAS A RARE FUNGAL INFECTION. THE INFECTION IS NOT AT THE WOUND. THE HOSPITAL DOES NOT BELIEVE THE INFECTION IS SURGERY RELATED, AND DOES NOT BELIEVE THE PATIENT WOULD HAVE CONTRACTED IT THROUGH THEIR OWN ACTIONS. THE PATIENT UNDERWENT A REVISION.
Patient problems: Fungal Infection; Osteolysis; Pain
MAUDE report 19384116 ↗InjuryApr 11, 2024Break; Degraded; Fracture; Break; Degraded; Fracture
IT WAS REPORTED THAT THE PATIENT STUBBED THEIR TOE 3 MONTHS POST-OP CAUSING THE IMPLANT TO FAIL, DEGRADING AND BREAKING LATERALLY. THE PATIENT UNDERWENT A REVISION SURGERY 5 MONTHS POST-OP.
Patient problems: Failure of Implant
MAUDE report 19093329 ↗InjuryDec 13, 2023Off-Label Use; Off-Label Use
IT WAS REPORTED THAT THE TENDON SPACER SIZER WAS IMPLANTED IN THE PATIENT. IT WAS DECIDED THAT A REVISION SURGERY WOULD BE PERFORMED TO REMOVE THE SIZER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18318730 ↗InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.
Patient problems: Loss of Range of Motion
MAUDE report 18022548 ↗InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.
Patient problems: Loss of Range of Motion
MAUDE report 18022547 ↗InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.
Patient problems: Loss of Range of Motion
MAUDE report 18022545 ↗InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.
Patient problems: Loss of Range of Motion
MAUDE report 18022531 ↗InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE CUSTOMER THAT 'ARHTROPLASTY OF THE SWANSON OF THE PPI IN 2013 AND FUNCTIONAL IMPOTENCE FOR 6 MONTHS: IMPLANT CHANGE + BIOPSY'.
Patient problems: Loss of Range of Motion
MAUDE report 16125620 ↗
Other Wright Medical Technology, Inc. products
- INFINITY51 models · 733 reports · 3 recalls
- INBONE56 models · 365 reports · 4 recalls
- INFINITY ADAPTIS8 models · 219 reports
- ORTHOLOC 3Di23 models · 28 reports · 2 recalls
- INFINITY BIOFOAM 3D5 models · 118 reports
- INFINITY EVERLAST20 models · 111 reports
- EVOLVE14 models · 28 reports · 1 recall
- FUSEFORCE8 models · 59 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page