Reported May 29, 2013 · Terminated
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325…
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Drive · Mahwah, NJ · 07430
Is this the product you have?
- Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used when there is a deficiency in the bone present during femoral preparation these devices are used to "fill the gap" between the implant and the bone
- Lot codes and dates
- Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
- Amount recalled
- 11 units
Where it was sold
Why it was recalled
Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.
This product could cause temporary or reversible health problems — stop using it.
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