Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon el

FDA device recall Z-1283-2015 · posted 2015-03-16 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.

Action taken

On March 20, 2015, Stryker sent Urgent Medical Device Recall Notifications/Urgent Medical Device Recall Notification Acknowledgement Forms dated March 19, 2015 to all affected customers. The letter identified the product, the related issue and the action to be taken by the customers. Customers were asked to return the attached acknowledgement form confirmed they received and reviewed the notification. Customers with questions were instructed to call 201-831-6365. Stryker sent an Urgent Medical Device Correction letter dated February 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the attached acknowledgement form confirming they have received and reviewed the letter. Customers with questions were instructed to call 201-831-6365.

Root cause

Device Design

Status

Terminated

Product code

MBH

Quantity affected

2030 units

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ire

Date initiated

2015-02-12

Date posted

2015-03-16

Date terminated

2016-07-05

Location

Mahwah, NJ

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