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

FDA device recall Z-1812-2008 · posted 2008-09-17 · Terminated

Recall details

Recalling firm

Depuy Orthopaedics, Inc.

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

NJL

Quantity affected

10

Distribution

Class II Recall - Nationwide Distribution --- including states of Pennsylvania and Virginia.

Date initiated

2008-05-06

Date posted

2008-09-17

Date terminated

2009-10-14

Location

Warsaw, IN