MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to 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 recall is classified as Severe because it involves a structural defect (component loosening) in a medical device that requires revision surgery, meeting the rubric criteria for significant injury or structural defects.
Plain-English summary
MicroPort Orthopedics Inc. is recalling the Advance II Modular Tibial Base with Screw Holes (REF KTTIHA20, Size 2 STD). The recall involves 110 units of the device, which is indicated for use in knee arthroplasty in skeletally mature patients.
The recall was initiated because the device is experiencing a higher than expected revision rate as a result of component loosening. This issue affects the structural integrity of the implant, necessitating further surgical intervention for patients who have received the device.
The affected units were distributed worldwide to Australia, Austria, France, Italy, Spain, and the United Kingdom. Patients who have received this specific implant should contact their healthcare provider to discuss their medical history and potential risks associated with the reported component loosening.
The recalled product
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 110
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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