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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy LCS Knee Meniscal bearing insert

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  Class 2 Device Recall Depuy LCS Knee Meniscal bearing insert see related information
Date Initiated by Firm May 06, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on October 14, 2009
Recall Number Z-1812-2008
Recall Event ID 48089
PMA Number P830055S058 
Product Classification Knee Prosthesis, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing - Product Code NJL
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.
Code Information Lot B2LE31000.
Recalling Firm/
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
Manufacturer 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.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.