Recall Z-1812-2008 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Depuy Orthopaedics, Inc.
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 k
| Date | Sep 17, 2008 (initiated May 6, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 10 |
| Distribution | Class II Recall - Nationwide Distribution --- including states of Pennsylvania and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.