MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 77 Advance II Modular Tibial Bases because they are experiencing higher than expected revision rates due to 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 (total knee implant) with a functional defect (loosening) that requires revision surgery, but the source text does not report specific injuries or fatalities, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 77 units of the ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES (REF KTTIHA41, SIZE 4+). These are sterile, HA-coated, porous-surface tibial bases intended for cementless use in total knee arthroplasty systems.
The recall was initiated because the devices are experiencing a higher than expected revision rate as a result of component loosening. The affected units were distributed worldwide only 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 further evaluation or intervention is necessary.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 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
- 77
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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