Recall Z-1575-2015
Zimmer, Inc. · initiated April 2, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Part #00-5990-036-10; lot 62815809
Reason for recall
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
FDA-determined cause: Mixed-up of materials/components
Action taken
On 4/2/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. All distributors were notified via electronic mail, and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Details
- Recall number
- Z-1575-2015
- Initiated
- April 2, 2015
- Posted by FDA
- May 1, 2015
- Terminated
- September 23, 2015
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 20 units
- Distribution
- Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
- Recalling firm
- Zimmer, Inc., Warsaw, IN