Truliant Splined Stem Extension recall: Labeling Error
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral…
Why was Truliant Splined Stem Extension recalled?
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076
- Product
- Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral…
- Recalling firm
- Exactech, Inc.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of AZ, CO and FL.
- Recall date
- March 4, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)