Z-1682-2011

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

Name: Z-1682-2011 SCORPIO PS 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 PS 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-1682-2011
Status: Terminated
Initiated: 2010-07-13
Posted: 2011-03-16
Terminated: 2017-09-29
Recalling firm: Howmedica Osteonics Corp
Product: SCORPIO PS 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: LXH Orthopedic Manual Surgical Instrument
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. 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: T72-3-0108M SCORPIO PS TIBIAL TRIAL, SIZE 1, 8 MM T72-3-0110M SCORPIO PS TIBIAL TRIAL, SIZE 1, 10 MM T72-3-0112M SCORPIO PS TIBIAL TRIAL, SIZE 1, 12 MM T72-3-0115M SCORPIO PS TIBIAL TRIAL, SIZE 1, 15 MM T72-3-0118M SCORPIO PS TIBIAL TRIAL, SIZE 1, 18 MM T72-3-0121M SCORPIO PS TIBIAL TRIAL, SIZE 1, 21 MM T72-3-0124M SCORPIO PS TIBIAL TRIAL, SIZE 1, 24 MM T72-3-0308M SCORPIO PS TIBIAL TRIAL, SIZE 3, 8 MM T72-3-0310M SCORPIO PS TIBIAL TRIAL, SIZE 3, 10 MM T72-3-0312M SCORPIO PS TIBIAL TRIAL, SIZE 3, 12 MM T72-3-0315M SCORPIO PS TIBIAL TRIAL, SIZE 3, 15 MM T72-3-0318M SCORPIO PS TIBIAL TRIAL, SIZE 3, 18 MM T72-3-0321M SCORPIO PS TIBIAL TRIAL, SIZE 3, 21 MM T72-3-0324M SCORPIO PS TIBIAL TRIAL, SIZE 3, 24 MM T72-3-0508M SCORPIO PS TIBIAL TRIAL, SIZE 5, 8 MM T72-3-0510M SCORPIO PS TIBIAL TRIAL, SIZE 5, 10 MM T72-3-0512M SCORPIO PS TIBIAL TRIAL, SIZE 5, 12 MM T72-3-0515M SCORPIO PS TIBIAL TRIAL, SIZE 5, 15 MM T72-3-0518M SCORPIO PS TIBIAL TRIAL, SIZE 5, 18 MM T72-3-0521M SCORPIO PS TIBIAL TRIAL, SIZE 5, 21 MM T72-3-0524M SCORPIO PS TIBIAL TRIAL, SIZE 5, 24 MM T72-3-0708M SCORPIO PS TIBIAL TRIAL, SIZE 7, 8 MM T72-3-0710M SCORPIO PS TIBIAL TRIAL, SIZE 7, 10 MM T72-3-0712M SCORPIO PS TIBIAL TRIAL, SIZE 7, 12 MM T72-3-0715M SCORPIO PS TIBIAL TRIAL, SIZE 7, 15 MM T72-3-0718M SCORPIO PS TIBIAL TRIAL, SIZE 7, 18 MM T72-3-0721M SCORPIO PS TIBIAL TRIAL, SIZE 7, 21 MM T72-3-0724M SCORPIO PS TIBIAL TRIAL, SIZE 7, 24 MM T72-3-0908M SCORPIO PS TIBIAL TRIAL, SIZE 9, 8 MM T72-3-0910M SCORPIO PS TIBIAL TRIAL, SIZE 9, 10 MM T72-3-0912M SCORPIO PS TIBIAL TRIAL, SIZE 9, 12 MM T72-3-0915M SCORPIO PS TIBIAL TRIAL, SIZE 9, 15 MM T72-3-0918M SCORPIO PS TIBIAL TRIAL, SIZE 9, 18 MM T72-3-0921M SCORPIO PS TIBIAL TRIAL, SIZE 9, 21 MM T72-3-0924M SCORPIO PS TIBIAL TRIAL, SIZE 9, 24 MM All lots.

Product code LXH

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)