Stryker Howmedica Osteonics Corp.: 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.

Recall number

Z-1682-2011

Recalling firm

Stryker 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.

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

T72-3-0108M 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.

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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