Z-0463-2014Class II

NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices...

Name: Z-0463-2014 NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices...
Creator: Zimmer, Inc.
Published: 2013-11-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-11-19 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated... on 2013-11-19. FDA classified it as Class II and gives the reason as "This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0463-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-19
Posted: 2013-12-06
Terminated: 2015-05-06
Recalling firm: Zimmer GmbH
Product: NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
Product code: HWT Template
Reason for recall: This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Zimmer sent an Urgent Medical Device Recall Notice dated November 19, 2013, to all affected customers. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product will be removed by a Zimmer Sales representative, Question should be directed to 1-877-946-2761 8a.m - 5 p.m. EST. For questions regarding this recall call 800-613-6131.
Quantity in commerce: 439 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
Product codes and lots: Part Number 00-5971-041-09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0463-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0459-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06
Z-0460-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06
Z-0461-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06
Z-0462-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06
Z-0463-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)