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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening."
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…
- 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.
See all 11 products in this recall →Related recalls
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