FDAClass IIMarch 23, 2016

Product 12 consists of all product under recall

Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM…

Why was Product 12 consists of all product 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 no62240860 62339639 62395853 62240859 62279765 62339640 62395852 62089508 62094969 62185962 62240862 62273366 62279766 61660149 62279769 62284368 62284368N 62284371 62093453

Product
Product 12 consists of all product under product code JDI , and same usage: Item no: 902602935 6 DEGREE COCR FEM HEAD 28 902602835 6 DEGREE COCR FEM…
Recalling firm
Zimmer Manufacturing B.V.
Quantity
209
Distribution
US Nationwide Distribution
Recall date
March 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls