NexGen LPS Femoral Component recall
NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Why was NexGen LPS Femoral Component recalled?
There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
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?
Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)
- Product
- NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
- Recalling firm
- ZIMMER ORTHOPEDIC MFG LTD
- Quantity
- 7 devices
- Distribution
- Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
- Recall date
- February 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)