Triathlon TS Femoral Trial; Size 7 Right Non-Sterile Catalog Number: 5512-T-702 Howmedica Osteonics Corp. 325 Corporate

FDA device recall Z-1585-2008 · posted 2008-07-26 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.

Action taken

Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

2

Distribution

Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.

Date initiated

2008-03-05

Date posted

2008-07-26

Date terminated

2010-10-25

Location

Mahwah, NJ