Z-0467-2010

Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The...

Name: Z-0467-2010 Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-10-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-10-02 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that... on 2009-10-02. The reason FDA records is "It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0467-2010
Status: Terminated
Initiated: 2009-10-02
Posted: 2009-12-01
Terminated: 2010-04-05
Recalling firm: Howmedica Osteonics Corp
Product: Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopaedics; 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.
Root cause tag: packaging
FDA root cause: Other
Action: An "Urgent Product Recall" letter was sent on October 2, 2009 by Federal Express to Stryker branches and Hospital Risk Management Departments in the United States as well as foreign consignees. The letter described the issue, potential hazard and actions for affected accounts. Consignees were instructed to examine their inventory and return recalled product as instructed in the notification letter to Stryker Orthopaedics. In addition, consignees were instructed to reconcile affected product by completing the attached Product Accountability form (with spreadsheet) and faxing to 1-201-831-6069. Direct questions to Stryker Orthopaedics by calling 1-201-972-2100.
Quantity in commerce: 77 of total product
Distribution: Worldwide Distribution -- United States (MA, NJ, IN, MI, CA and PA), Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, and the United Kingdom.
Product codes and lots: Catalog number 70-4107R, Lot code MHHDME.

Product code JWH

K974556Class IIOsteonics Scorpio Posterior Cruciate Retaining Total Knee SystemOsteonics Corp. / cleared 1998-02-27

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)