FDAFDA · Food and drugs·Recall number Z-2390-2016
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Published August 17, 2016 · Recall initiated: June 23, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
- Lot
- Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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