Z-1741-2011

CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial...

Name: Z-1741-2011 CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial...
Creator: Ortho Development Corporation
Published: 2011-01-07
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2011-01-07 / Terminated / root cause: labeling and UDI

FDA source

Ortho Development Corporation began a recall of CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray... on 2011-01-07. The reason FDA records is "Components of a replacement knee system could be mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1741-2011
Status: Terminated
Initiated: 2011-01-07
Posted: 2015-06-26
Terminated: 2011-12-27
Recalling firm: Ortho Development Corp.
Product: CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Components of a replacement knee system could be mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm, Ortho Development, sent a "Field Notification Memo" date January 7, 2011 to its customers. The memo described the product, problem and action to be taken. The customers were instructed to promptly return any remaining parts of the listed product; locate all the parts in their inventory; identify any of the listed parts that may have been used in surgery; verify the quantity they have on hand and the quantity used in surgery and reconcile them with the quantity sent; if discrepancy exists, notify customer service resolution; prepare items for return and contact customer service to obtain RMA number. Once reconciled, arrangements would be made for sending new inventory and the return of unused parts. If you have any questions regarding this issue, please notify Regulatory Affairs Manager at (801) 619-3450.
Quantity in commerce: 14 units (US), 2 (Intnl)
Distribution: Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
Product codes and lots: Lot Number: 67224

Product code JWH

K060569Class IIBalanced Knee System Modular Revision Knee SystemOrtho Development Corp. / cleared 2006-07-06

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)