FDAClass IIFebruary 21, 2018

Norian Drillable Inject recall

Norian Drillable Inject

Why was Norian Drillable Inject recalled?

The contract supplier notified DePuy Synthes on June 16, 2017 that the kit expiration dates do not align with the earliest expiration date of the component lots within the kit. Some kit expiration dates were later than the earliest expiration date of the component lots. The expiration dates of some components are earlier than that listed on the kit.

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?

Product Number: 07.704.010S Lot Number: DSE0733

Product
Norian Drillable Inject
Recalling firm
Synthes USA
Quantity
5 units
Distribution
Nationwide Distribution.
Recall date
February 21, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls