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).
- Recall Initiated
- February 12, 2015
- Posted
- March 16, 2015
- Terminated
- July 5, 2016
- Recall Number
- Z-1283-2015
- Quantity
- 2030 units
- Firm Location
- Mahwah, NJ
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.
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, Ireland, Kuala Lumpar, New Zealand and South Africa.
Lot / Code Info
ER5ND5 ER6EG4 ER5NE4 ER6EG5 ER5NE4M ER6EG5A ER6CG9 ER6KA1 ER6CG9A ER6KA2 ER6CH1 ER6KA3 ER6CH1A ER6KA3A ER6CH1D ER6KA3T ER6CH1M ER6KA4 ER6ED1 ER6KA5 ER6ED1A ER6KA6 ER6ED2 ER6KA7 ER6ED3 ER6KA7T ER6ED4 ER6KA8 ER6ED5 ER6KA8T ER6ED6 ER6KA9 ER6ED7 ER6KD1 ER6ED7E ER6KD2 ER6ED8 ER6KD3 ER6ED8J ER6KD4 ER6ED9 ER6KD5 ER6EE1Y ER6KD6 ER6EE2 ER6KD7 ER6EE6 ER6MA3 ER6EE6M ER6MA4 ER6EE7 ER6SA3 ER6EE7J ER6SA3J ER6EF2 ER6SA3X ER6EF3 ER6SA4 ER6EF3A ER7MA3 ER6EF4 ER7MA3D ER6EF4M ER7MA3M ER6EF5 ER7MA3T ER6EF6 ER7MA4 ER6EF6P ER7MA4A ER6EF8 ER7MA4E ER6EF9 ER7MA4T ER6EG2 ER8SK2 ER6EG3 ER8SK2M ER8SK2P ER8SK3 ER8SK3X ER8SK4 ER8SK4A ER8SK4T ER8WA6 ER8WA6P ER8WA6X ER8WA9 ER8WA9A ER8WA9P ER9CH0 ER9CH0A ER9EA7
Root Cause
Device Design
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.