MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe) due to the potential for serious adverse health consequences.
Plain-English summary
MicroPort Orthopedics Inc. is recalling the ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES (REF KTTIHA50, SIZE 5 STD). The recall involves 60 units of the device, which is indicated for use in knee arthroplasty in skeletally mature patients.
The recall was initiated because the device is experiencing a higher than expected revision rate as a result of component loosening. The affected units were distributed worldwide to Australia, Austria, France, Italy, Spain, and the United Kingdom.
Patients who have received this specific implant should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if any follow-up care or revision surgery is necessary.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 11 recalled by MicroPort Orthopedics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · MicroPort Orthopedics Inc.
See all →- ModerateReusable hip trial components recalled over missing FDA premarket authorization
FDA (Devices) · 2026-01-28
- ModerateFemoral Knee Prosthesis Components May Have Incorrect Packaging
FDA (Devices) · 2024-12-25
- HighMicroPort Knee Implant Recall: Wrong Size Component in Packaging
FDA (Devices) · 2024-07-10
- HighMicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging
FDA (Devices) · 2023-02-22
- HighEVOLUTION MP Tibial Base knee component recalled for wrong product in packaging
FDA (Devices) · 2023-02-22
Same hazard · component loosening
See all →- HighTDC VELOCE 23 gauge vitrectomy cutters may have loose outer knife
FDA (Devices) · 2026-06-17
- HighTDC VELOCE 27 gauge vitrectomy cutters may have loose outer knife
FDA (Devices) · 2026-06-17
- HighTDC VELOCE 25 gauge vitrectomy cutters may have loose outer knife
FDA (Devices) · 2026-06-17
- HighFresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor
FDA (Devices) · 2024-05-29
- SevereMicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
FDA (Devices) · 2016-09-14