Stryker Howmedica Osteonics Corp.: SCORPIO-FLEX 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.

Recall number

Z-1683-2011

Recalling firm

Stryker Howmedica Osteonics Corp.

Product

SCORPIO-FLEX 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.

Status

Terminated

Initiated

2010-07-13

Posted

2011-03-16

Terminated

2017-09-29

Reason

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).

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

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.

Lot, serial or model codes

T72-5-0308A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 8 MM T72-5-0310A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 10 MM T72-5-0312A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 12 MM T72-5-0315A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 15 MM T72-5-0318A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 18 MM T72-5-0321A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 21 MM T72-5-0324A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 3, 24 MM T72-5-0508A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 8 MM T72-5-0510A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 10 MM T72-5-0512A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 12 MM T72-5-0515A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 15 MM T72-5-0518A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 18 MM T72-5-0521A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 21 MM T72-5-0524A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 5, 24 MM T72-5-0708A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 8 MM T72-5-0710A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 10 MM T72-5-0712A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 12 MM T72-5-0715A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 15 MM T72-5-0718A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 18 MM T72-5-0721A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 21 MM T72-5-0724A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 7, 24 MM T72-5-0908A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 8 MM T72-5-0910A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 10 MM T72-5-0912A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 12 MM T72-5-0915A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 15 MM T72-5-0918A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 18 MM T72-5-0921A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 21 MM T72-5-0924A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 9, 24 MM T72-5-1108A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 8 MM T72-5-1110A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 10 MM T72-5-1112A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 12 MM T72-5-1115 SCORPIO SUPERFLEX PS TIB.TRIAL, SIZE 11, 15 MM T72-5-1115A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 15 MM T72-5-1118A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 18 MM T72-5-1121A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 21 MM T72-5-1124A SCORPIO-FLEX PS TIBIAL TRIAL, SIZE 11, 24 MM T72-3-1108M INSERTOS DE PRUEBA, SIZE 11, 8 MM T72-3-1110M INSERTOS DE PRUEBA, SIZE 11, 10 MM All lots

510(k) numbers

not on file

PMA numbers

not on file

Product code

LXH

Firm FEI

3003070421

Firm city

Mahwah

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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