MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 38 units of Advance II Modular Tibial Bases because they are experiencing a higher than expected revision rate due to 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, which aligns with the rubric criteria for a Severe (4) rating involving structural defects or significant injury reports.
Plain-English summary
MicroPort Orthopedics Inc. is recalling 38 units of the ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, REF KTTIHA60, SIZE 6 STD. The device is a sterile, porous, HA-coated knee tibial base intended for cementless use in total knee arthroplasty.
The recall was initiated because the product is 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 had this specific device implanted should contact their orthopedic surgeon or healthcare provider to discuss the recall and determine if any follow-up care is necessary.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 38
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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