3DKnee e+ Tibial Insert. The insert is used along with recall
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Why was 3DKnee e+ Tibial Insert. The insert is used along with recalled?
U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled.
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/Catalog Number 391-15-708. Lot/Serial Number 59602230.
- Product
- 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
- Recalling firm
- Encore Medical, Lp
- Quantity
- 5
- Distribution
- US Distribution to the state of California and International Distribution to the country of Venezuela.
- Recall date
- May 8, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)