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Terminated

Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; Catalog number 5532-G-713, Catalog number 5532-G-813 Stryker Orthopaedics

FDA Recall Z-1013-2009 · Posted 2009-03-03

Recall StatusTerminated
Product CodeJWH
Date Initiated2008-12-18
Date Terminated2012-09-11
Product Quantity9 of lot code LBD528; 14 of lot code LBD512

Reason for Recall

Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior Stabilized Tibial Insert Size 8-13 mm)

Firm Action

Urgent Product Recall letters were sent via Federal Express on December 18, 2008 with return receipt to Stryker branches, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation factors. The firm asked customers to examine their inventory and hospital locations to identify affected product; retrieve all affected product and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form; and return affected product. Questions should be directed to Karen Ariemma at 201-831-5718.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution: FL and IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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