Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components. Sze 7, THKNS 13 m and SZE 8, T

FDA device recall Z-1013-2009 · posted 2009-03-03 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

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)

Action taken

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

Status

Terminated

Product code

JWH

Quantity affected

9 of lot code LBD528; 14 of lot code LBD512

Distribution

Nationwide Distribution: FL and IL.

Date initiated

2008-12-18

Date posted

2009-03-03

Date terminated

2012-09-11

Location

Mahwah, NJ

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