Z-1575-2015Class II

NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee...

Name: Z-1575-2015 NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee...
Creator: Zimmer, Inc.
Published: 2015-04-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-04-02 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of 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... on 2015-04-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1575-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-02
Posted: 2015-05-01
Terminated: 2015-09-23
Recalling firm: Zimmer GmbH
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: 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.
Quantity in commerce: 20 units
Distribution: Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
Product codes and lots: Part #00-5990-036-10; lot 62815809

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1575-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1575-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-13	2015-05-01

Product code JWH

K960279Class IINexgen Compl. Knee Sol. Legacy Posterior Stabilized/constrained Condylar Knee Femoral Components/articular SurfacesZimmer, Inc. / cleared 1996-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)