Z-1315-2021Class II

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System -

Name: Z-1315-2021 The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System -
Creator: DePuy Orthopaedics, Inc.
Published: 2021-02-22
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-02-22 / Terminated / root cause: packaging

FDA source

DePuy Orthopaedics, Inc. began a recall of The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and... on 2021-02-22. FDA classified it as Class II and gives the reason as "Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases...". 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-1315-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-22
Posted: 2021-03-29
Terminated: 2023-10-11
Recalling firm: Depuy Orthopaedics Inc.
Product: The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: On 02/25/2021, Depuy Synthes issued an Urgent Medical Device Recall notices to customers via email. DePuy (Ireland) UC is initiating a voluntary removal for the 12 lots for ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Quantity in commerce: 102 units total (Domestic: 0 units, Foreign: 162 units)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.
Product codes and lots: Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1315-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1315-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-29
Z-1316-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-07	2021-03-29

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)