Stem Trial, Triathlon Revision Instruments; Non-Sterile; 100 mm length Catalog numbers: 5565-T-009, 5565-T-010, 5565-T-0

FDA device recall Z-2157-2008 · posted 2008-08-23 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.

Action taken

Urgent Product Recall notification letters were sent to all Stryker Branch/Agency Manager/Quality contacts on May 14, 2008 via Federal Express. The letter requests that consignees examine their inventory and hospital consignment locations to identify the product; and retrieve all affected product lots and return it to their branch or agency warehouse for reconciliation. The letter also states that a Stryker Orthopaedics Customer Service rep should be contacted for alternative products available.

Root cause

Process control

Status

Terminated

Product code

HWT

Quantity affected

Catalog Number 5565 T-009 to 025: 2629 US, 238 international: Catalog 5566 T-009 to 025: 2625 US, 239 international

Distribution

Worldwide Distribution --- including USA and countries of Australia, Canada, Sweden, Germany, Spain, Portugal, United Kingdom.

Date initiated

2008-05-14

Date posted

2008-08-23

Date terminated

2010-01-26

Location

Mahwah, NJ