GMK Hinge knee prosthesis recall
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Why was GMK Hinge knee prosthesis recalled?
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
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?
Lot: 145129
- Product
- GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
- Recalling firm
- Medacta Usa
- Quantity
- 4 units (US)
- Distribution
- Distributed in the states of IL, OH and UT, and the countries of in Austria, Spain, Australia, France and Switzerland.
- Recall date
- November 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)