3DKnee e+ Tibial Insert - HXLPE-VE recall: Labeling Error
3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the…
Why was 3DKnee e+ Tibial Insert - HXLPE-VE recalled?
The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
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?
Model Number 392-09-706, Lot Number 59602519
- Product
- 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the…
- Recalling firm
- Encore Medical, Lp
- Quantity
- 7 units
- Distribution
- Worldwide Distribution including Venezuela.
- Recall date
- September 5, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)