Z-1575-2015 Class II Terminated
FDA device recall Z-1575-2015 was initiated by Zimmer, Inc. on Apr 2, 2015 and is designated Class II. 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… The recall status is terminated (terminated Sep 23, 2015). Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2015
- Initiation Date
- Apr 2, 2015
- Termination Date
- Sep 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
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.
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
Distribution Pattern
Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
Code Information
Part #00-5990-036-10; lot 62815809
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1575-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026