Zeus-P Lumbar Interbody Device recall: Labeling Error
Zeus-P Lumbar Interbody Device
Why was Zeus-P Lumbar Interbody Device recalled?
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
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?
Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
- Product
- Zeus-P Lumbar Interbody Device
- Recalling firm
- Amendia, Inc
- Quantity
- 25 units
- Distribution
- US Distribution to the states of : GA. MI, OK, SC, TX, VA
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)