Tibial Alignment Handle Triathlon Instruments CAT #: 6541-2-807 Nav Tibial Alignment Handle Triathlon Instruments CAT #;

FDA device recall Z-1619-2012 · posted 2012-05-17 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker received a Product Experience Report (PER) that a swivel block was improperly oriented on a Triathlon Tibial Alignment Handle, catalog no. 6541-2-807.

Action taken

Stryker sent an Urgent Product Field Action letter dated October 10, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of the affected product . Customers were asked to fax back the attached Poroduct Field Action Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers were instructed to call 201-972-2100. For questions regarding this recall call 201-831-3523.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

6,126 Units

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan

Date initiated

2011-10-10

Date posted

2012-05-17

Date terminated

2014-09-10

Location

Mahwah, NJ