Stryker Triathlon Femoral Distal Augment Recalled for Packaging Label Errors
Stryker Howmedica Osteonics is recalling 11 units of Triathlon Femoral Distal Augments due to external packaging label errors, including an incorrect glyph and missing size reference.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves minor labeling errors on external packaging without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 11 units of the Stryker Orthopaedics Triathlon Femoral Distal Augment- Left. The recall involves specific catalog number 5541-A-501 and lot codes HALY, HAOO, and HANG. These devices are used to fill gaps between the implant and bone during femoral preparation.
The recall was initiated after Stryker Orthopaedics received a report that the label on the external packaging box depicted a glyph of an acetabular shell rather than a femoral distal augment. Additionally, the label was missing a reference to the "10mm" augment thickness, which is required to appear below the size reference on the label print.
The affected units were distributed nationwide in the United States, including Hawaii, Indiana, Mississippi, North Carolina, New Jersey, Oklahoma, Texas, and Wisconsin. Healthcare providers should verify their inventory against the specific catalog and lot numbers listed and stop using the affected devices.
The recalled product
- Product
- 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 w
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalog Number 5541-A-501 Lot Codes HALY
- HAOO
- HANG
Distribution
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