FDA-Device2015-05-13Class II
NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
Zimmer, Inc.
Hazard
The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery
Sold states
Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
Affected count
20 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1575-2015Don't want to check this manually?
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