Recalls / —
—#138725
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.
- FDA product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K141056
- Affected lot / code info
- Catalog number 5530-G-209 Lot Code LEF064
Why it was recalled
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).
Root cause (FDA determination)
Labeling mix-ups
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2006
Distribution
- Distribution pattern
- OH, SC, RI, WV
Timeline
- Recall initiated
- 2015-05-29
- Posted by FDA
- 2015-08-14
- Terminated
- 2016-09-26
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138725. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.