FDAClass IIMarch 23, 2016

Product 15 consists of all recall

Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM…

Why was Product 15 consists of all recalled?

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

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?

lot no.: 62154349 62263555 62270747 62315652 62389960 62212034 62270748 62389957 37107513 62154348 62212021 62270746 62299145 62389956 62299145N

Product
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM…
Recalling firm
Zimmer Manufacturing B.V.
Quantity
0
Distribution
US Nationwide Distribution
Recall date
March 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls