Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
This recall has been terminated (originally issued August 10, 2015).
- Recall Initiated
- May 29, 2015
- Posted
- August 10, 2015
- Terminated
- July 25, 2016
- Recall Number
- Z-2360-2015
- Quantity
- 26 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a 5532-G-511 Triathlon PS Stibialism Insert.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
Catalog Number 5532-G-511 Lot LD8D7Y Catalog Number 5537-G-319 Lot TT6JT2
Root Cause
Under Investigation by firm
Action Taken
Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated July 9, 2015 and Product Accountability Forms via return receipt. The letter identified the affected product, problem, potential hazard, risk mitigation and actions to be taken. Contact Stryker Orthopaedics Sales Representative to arrange for return of the affected product. For questions call 201-831-5826.