Equinoxe Platform Fracture Stem recall
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Why was Equinoxe Platform Fracture Stem recalled?
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
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: 304-22-07; Serial Range: 4971292-4971303
- Product
- Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
- Recalling firm
- Exactech, Inc.
- Quantity
- 12 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
- Recall date
- November 4, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)