MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 47 units of 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 involves a structural defect (component loosening) in a medical device that has resulted in a higher than expected revision rate, which aligns with the rubric criteria for 'structural vehicle defect' or 'significant injury/property-damage reports' (interpreted here as significant clinical failure requiring revision).
Plain-English summary
MicroPort Orthopedics Inc. is recalling 47 units of the ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES (REF KTTIHA51, SIZE 5+). The recalled devices are sterile, cementless, and HA coated, intended for use in knee arthroplasty. The recall is being conducted due to a higher than expected revision rate resulting from component loosening.
The affected units were distributed worldwide only to Australia, Austria, France, Italy, Spain, and the United Kingdom. The source text does not specify specific lot numbers or dates of distribution.
Patients who have received this device should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if a revision procedure is necessary. The source text does not provide specific instructions for consumers beyond the general recommendation to consult a medical professional.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; 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 Sy
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 47
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.
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