FDAClass IIJuly 22, 2015

Apex ARC Hip Stem recall

Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision…

Why was Apex ARC Hip Stem recalled?

Product may breach the inner and outer sterile pouches during shipping or handling.

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 Numbers: 5679, 5777, 7420, 7588, 7787, 8369, 8605, 8869, 9485, 9688, 18070

Product
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision…
Recalling firm
Omnilife Science Inc.
Quantity
146 devices
Distribution
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls