Nexgen Trabecular Metal Femoral Augment Block Distal recall: Labeling Error
NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe…
Why was Nexgen Trabecular Metal Femoral Augment Block Distal recalled?
One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
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?
20 MM - Part No. 00-5490-034-24, Lot #613574282T 5 MM - Part No. 00549003410, Lot #61357484T
- Product
- NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY, 20 MM Augment, Size D, Sterile, Rx Only. Product Usage: Intended for use where severe…
- Recalling firm
- Zimmer Trabecular Metal Technology, Inc.
- Quantity
- 1 unit
- Distribution
- US Distribution in the state of CA
- Recall date
- April 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)