Advance(r) II Modular Tibial Base W/screwholes recall
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…
Why was Advance(r) II Modular Tibial Base W/screwholes recalled?
ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
all codes
- 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…
- Recalling firm
- MicroPort Orthopedics Inc.
- Quantity
- 110 units
- Distribution
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- Recall date
- September 14, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)