Z-1812-2008

Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy...

Name: Z-1812-2008 Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy...
Creator: Depuy Orthopaedics, Inc.
Published: 2008-05-06
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2008-05-06 / Terminated / root cause: manufacturing process

FDA source

Depuy Orthopaedics, Inc. began a recall of Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025)... on 2008-05-06. The reason FDA records is "Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1812-2008
Status: Terminated
Initiated: 2008-05-06
Posted: 2008-09-17
Terminated: 2009-10-14
Recalling firm: Depuy Orthopaedics Inc.
Product: Depuy LCS Knee - Orthopedic knee implant. Meniscal bearing insert, Sz: STD, mm thick 12 5, sterile; Depuy Orthopaedics, Inc., Warsaw, IN; REF 1178-21-025). Product is a prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing intended to to allow for motion between the plastic bearing and metal baseplate components of a knee prosthesis. It is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis, inflammatory arthritis, traumatic arthritis, and revision of failed knee prostheses.
Product code: NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: Labeling Discrepancy -- Mislabeled and mis-etched as to size. Inserts were labeled and packaged as size Standard, 12.5mm Inserts but were actually a 10mm Inserts. Risks include but not limited to: a delay in the procedure while the proper component is located, and tight joint with constricted movement as a result of implantation of the wrong thickness of insert.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 5/6/08 an Urgent Information - Recall Notice and an User Facility Reconciliation Report was issued to all customers/consignees informing them to find and return any product on hand and the one implanting surgeon was also notified via letter. If you have any questions contact Steve Dowell at 1-800-366-8143.
Quantity in commerce: 10
Distribution: Class II Recall - Nationwide Distribution --- including states of Pennsylvania and Virginia.
Product codes and lots: Lot B2LE31000.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)