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.
This recall has been terminated (originally issued August 14, 2015).
- Recall Initiated
- May 29, 2015
- Posted
- August 14, 2015
- Terminated
- September 26, 2016
- Recall Number
- Z-2389-2015
- Quantity
- 10 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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).
Distribution
OH, SC, RI, WV
Lot / Code Info
Catalog number 5530-G-209 Lot Code LEF064
Root Cause
Labeling mix-ups
Action Taken
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.
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