INFINITY™ ADAPTIS™ 33680143Recalls & reported problems
Wright Medical Technology, Inc. · Class 2
All models of INFINITY ADAPTIS (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889797102339), received between May 23, 2025 and May 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K123954); they may or may not involve this specific model.
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
- Break1
- Fracture1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 23, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE: "IMPACTOR ARM BROKE DURING IMPLANT IMPACTION, LEAVING A BROKEN METAL SHARD IN THE PATIENT. SURGEON HAD TO DO EXTRA INCISION TO REMOVE IT. IT WAS REMOVED FROM THE PATIENT. THE SURGERY CONTINUED AS PLANNED AND THE OUTCOME EXPECTED WAS RECEIVED. THERE WAS HARM TO THE PATIENT, THERE WAS AN EXTRA HOUR TO THE TOURNIQUET TIME AND AN EXTRA UNPLANNED INCISION HAD TO BE MADE TO RETRIEVE IT."
Patient problems: Insufficient Information
MAUDE report 22078117 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123954. One submission often covers many models, so check the product and lot details in each record.
- Z-1477-2024 · Mar 6, 2024 · Open, Classifiedstryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
- Z-2105-2023 · Jun 13, 2023 · Open, ClassifiedStryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Other PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- Vantage 350-22-03Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls2 reports
- Vantage 350-21-04Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer2 recalls0 reports
- INFINITY 33630023Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER60 reports
- INFINITY 33600020Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Vantage 350-22-02Exactech, Inc. · Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer1 recall5 reports
- INFINITY 33650003Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER55 reports
- INFINITY 33630022Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER54 reports
- INFINITY 33600030Wright Medical Technology, Inc. · PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall4 reports
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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