FDAClass IIMarch 23, 2016

Product 7 consists of all products under recall

Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X…

Why was Product 7 consists of all products under 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: 62230449 62081271 62133855 62159156 62047629 62127760 61903333 62261628 61830478 61830479 62138082 62230452 61800380 61800381

Product
Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X…
Recalling firm
Zimmer Manufacturing B.V.
Quantity
109
Distribution
US Nationwide Distribution
Recall date
March 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls