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
|