U2 Total Knee System Tibial Insert recall: Labeling Error
U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for…
Why was U2 Total Knee System Tibial Insert recalled?
UOC received a customer compliant report from our distributor on October 31, 2017 which stated that contents of the package do not match the product labeling.
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 number 17B621AG
- Product
- U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for…
- Recalling firm
- United Orthopedic Corporation
- Quantity
- 14 pieces
- Distribution
- Worldwide Distribution - US Distribution and to the countries of: UK, Iran, Greece, Pakistan, Switzerland, France, China, Taiwan, Italy, Korea and South Africa.
- Recall date
- March 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)