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Terminated

Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).

FDA Recall Z-1283-2015 · Posted 2015-03-16

Recall StatusTerminated
Product CodeMBH
Date Initiated2015-02-12
Date Terminated2016-07-05
Product Quantity2030 units

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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