Z-1672-2015Class II

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic...

Name: Z-1672-2015 LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic...
Creator: DePuy Orthopaedics, Inc.
Published: 2015-03-04
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2015-03-04 / Terminated

FDA source

DePuy Orthopaedics, Inc. began a recall of LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery on 2015-03-04. FDA classified it as Class II and gives the reason as "The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1672-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-04
Posted: 2015-05-26
Terminated: 2015-10-30
Recalling firm: Depuy Orthopaedics Inc.
Product: LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
FDA root cause: Unknown/Undetermined by firm
Action: On 3/4/2015, URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System and on 3/19/2015 REVISED URGENT INFORMATION - DEVICE CORRECTION NOTICE for the LCS COMPLETE RPS Knee System (Revised) notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. 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. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. to 5 p.m. EDT).
Quantity in commerce: 19,059
Distribution: Worldwide Distribution-US (nationwide) and the countries of CANADA, AUSTRALIA, AUSTRIA, BELGIUM, UK, FRANCE, GREECE, IRELAND, ISRAEL, ITALY, KOREA, LUXEMBOURG, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, SOUTH AFRICA, SWITZERLAND, THAILAND.
Product codes and lots: All Lots. Catalog numbers: 129411010 129411020 129411030 129411040 129411050 129411060 129411070 129412010 129412020 129412030 129412040 129412050 129412060 129412070 129495040 129495050 129495060 129496040 129496050 129496060

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1672-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1672-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26
Z-1673-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26

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