Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive,

FDA device recall Z-1061-2013 · posted 2013-04-05 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.

Action taken

Stryker sent Notification Letters/Product Accountablility Forms dated March 1, 2013 via FedEx to their Branches/Agencies on March 1, 2013.. Notification Letters/Product Recall Acknowledgement Forms dated March 4, 2013, were sent via FedEx to Hospital Risk Management on March 4, 2013. The Notification letters identified the product, the problem, and instructed customers on how to identify affected product; informs customers of the issues and potential hazards with the affected product and instructs them to contact their representative to arrange for return/replacement of any affected product. Customers are also asked to fax back the provided "Urgent Medical Device Removal Notification Acknowledgement Form" to Stryker within 5 days of receipt. Customers with questions were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5523.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JWH

Quantity affected

871 units

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.

Date initiated

2013-02-23

Date posted

2013-04-05

Date terminated

2015-06-15

Location

Mahwah, NJ