Z-0663-2018Class II

NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total...

Name: Z-0663-2018 NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total...
Creator: Zimmer Orthopedic Mfg Ltd
Published: 2017-07-24
License: https://open.fda.gov/license/

Zimmer Orthopedic Mfg Ltd / initiated 2017-07-24 / Terminated / root cause: packaging

FDA source

ZIMMER ORTHOPEDIC MFG LTD began a recall of NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty on 2017-07-24. FDA classified it as Class II and gives the reason as "There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation". 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-0663-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Posted: 2018-02-21
Terminated: 2018-04-16
Recalling firm: Zimmer Orthopedic Mfg Ltd
Product: NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
Root cause tag: packaging
FDA root cause: Reprocessing Controls
Action: On approximately July 24, 2017, customers were notified via letter of the recall. Instructions for distributors included to ensure affected personnel are aware of the recall, locate and quarantine any affected product in inventory, complete and return the Inventory Return Certification Form, make arrangements to return the product Zimmer Biomet, and provide customers if product was further distributed. Instructions for Risk Managers at medical facilities include to ensure affected personnel are aware of the recall, to assist the Zimmer Biomet sales representative in identifying and quarantining affected devices so they can be removed by the sales representative, and to complete and return the Certification of Acknowledgement form. Further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. or 1 (800) 613-6131
Quantity in commerce: 7 devices
Distribution: Worldwide Distribution - US Distribution to the states of : CA, MA, ME, MI, MN and WI., and to the countries of Germany, France and Italy.
Product codes and lots: Item Number: 00-5964-017-51, Lot Numbers (UDI Number): 63329529 ((01) 00889024001152 (17) 260430 (10) 63329529); 63342472 ((01) 00889024001152 (17) 260430 (10) 63342472); 63329533 ((01) 00889024001152 (17) 260430 (10) 63329533); 63329527 ((01) 00889024001152 (17) 260430 (10) 63329527)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0663-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0663-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-21

Product code NJL

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)