Z-1681-2011

SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah...

Name: Z-1681-2011 SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2010-07-13
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2010-07-13 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during... on 2010-07-13. The reason FDA records is "Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024" (0.6mm)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1681-2011
Status: Terminated
Initiated: 2010-07-13
Posted: 2011-03-16
Terminated: 2017-09-29
Recalling firm: Howmedica Osteonics Corp
Product: SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024" (0.6mm).
FDA root cause: Other
Action: Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201-831-6069. For any questions customers were to call 201-972-2100 or 201-831-5028.
Quantity in commerce: 159,095 units, all types.
Distribution: Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.
Product codes and lots: T72-2-0308 SCORPIO CR TIBIAL TRIAL, SIZE 3, 8 MM T72-2-0310 SCORPIO CR TIBIAL TRIAL, SIZE 3, 10 MM T72-2-0312 SCORPIO CR TIBIAL TRIAL, SIZE 3, 12 MM T72-2-0315 SCORPIO CR TIBIAL TRIAL, SIZE 3, 15 MM T72-2-0318 SCORPIO CR TIBIAL TRIAL, SIZE 3, 18 MM T72-2-0321 SCORPIO CR TIBIAL TRIAL, SIZE 3, 21 MM T72-2-0324 SCORPIO CR TIBIAL TRIAL, SIZE 3, 24 MM T72-2-0508 SCORPIO CR TIBIAL TRIAL, SIZE 5, 8 MM T72-2-0510 SCORPIO CR TIBIAL TRIAL, SIZE 5, 10 MM T72-2-0512 SCORPIO CR TIBIAL TRIAL, SIZE 5, 12 MM T72-2-0515 SCORPIO CR TIBIAL TRIAL, SIZE 5, 15 MM T72-2-0518 SCORPIO CR TIBIAL TRIAL, SIZE 5, 18 MM T72-2-0521 SCORPIO CR TIBIAL TRIAL, SIZE 5, 21 MM T72-2-0524 SCORPIO CR TIBIAL TRIAL, SIZE 5, 24 MM T72-2-0708 SCORPIO CR TIBIAL TRIAL, SIZE 7, 8 MM T72-2-0710 SCORPIO CR TIBIAL TRIAL, SIZE 7, 10 MM T72-2-0712 SCORPIO CR TIBIAL TRIAL, SIZE 7, 12 MM T72-2-0715 SCORPIO CR TIBIAL TRIAL, SIZE 7, 15 MM T72-2-0718 SCORPIO CR TIBIAL TRIAL, SIZE 7, 18 MM T72-2-0721 SCORPIO CR TIBIAL TRIAL, SIZE 7, 21 MM T72-2-0724 SCORPIO CR TIBIAL TRIAL, SIZE 7, 24 MM T72-2-0908 SCORPIO CR TIBIAL TRIAL, SIZE 9, 8 MM T72-2-0910 SCORPIO CR TIBIAL TRIAL, SIZE 9, 10 MM T72-2-0912 SCORPIO CR TIBIAL TRIAL, SIZE 9, 12 MM T72-2-0915 SCORPIO CR TIBIAL TRIAL, SIZE 9, 15 MM T72-2-0918 SCORPIO CR TIBIAL TRIAL, SIZE 9, 18 MM T72-2-0921 SCORPIO CR TIBIAL TRIAL, SIZE 9, 21 MM T72-2-0924 SCORPIO CR TIBIAL TRIAL, SIZE 9, 24 MM T72-2-1108 SCORPIO CR TIBIAL TRIAL, SIZE 11, 8 MM T72-2-1110 SCORPIO CR TIBIAL TRIAL, SIZE 11, 10 MM T72-2-1112 SCORPIO CR TIBIAL TRIAL, SIZE 11, 12 MM T72-2-1115 SCORPIO CR TIBIAL TRIAL, SIZE 11, 15 MM T72-2-1118 SCORPIO CR TIBIAL TRIAL, SIZE 11, 18 MM T72-2-1121 SCORPIO CR TIBIAL TRIAL, SIZE 11, 21 MM T72-2-1124 SCORPIO CR TIBIAL TRIAL, SIZE 11, 24 MM All lots.

Product code JWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)