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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = MBH
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