Stryker Orthopaedics Triathlon Femoral Distal Augment recall
Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430…
Why was Stryker Orthopaedics Triathlon Femoral Distal Augment 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number 5541-A-501 Lot Codes HALY, HAOO, HANG
- Product
- Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 11 units
- Distribution
- Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.
- Recall date
- May 29, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)