MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases because of a higher-than-expected revision rate caused by component loosening.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a structural defect (component loosening) that leads to revision surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 36 units of the ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES (REF KTTIHA11, SIZE 1+). The recalled device is a sterile, porous, HA-coated knee tibial base intended for cementless use in total knee arthroplasty. The product was distributed worldwide to Australia, Austria, France, Italy, Spain, and the United Kingdom.
The recall was initiated due to a higher-than-expected revision rate resulting from component loosening. The source text does not report any specific injuries, illnesses, or fatalities associated with this defect.
Patients who have had this specific device implanted should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if further evaluation or intervention is necessary.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 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
- 36
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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