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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert

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  Class 2 Device Recall Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert see related information
Date Initiated by Firm May 29, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on September 26, 2016
Recall Number Z-2389-2015
Recall Event ID 71678
510(K)Number K141056  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
Product Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR
REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
Code Information Catalog number 5530-G-209   Lot Code LEF064
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Paul Jahnke
201-831-5826
Manufacturer Reason
for Recall		 Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209).
FDA Determined
Cause 2		 Labeling mix-ups
Action Stryker Orthopaedics sent a recall notification via email on 5/29/2015 to their local branches. Notification letters and Product Accountability Forms were sent to Stryker branches/agencies with return receipts on 7/2/2015.
Quantity in Commerce 10 units
Distribution OH, SC, RI, WV
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = STRYKER ORTHOPAEDICS
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