FDAClass IIAugust 1, 2018

OMNI Hip System recall

OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is…

Why was OMNI Hip System recalled?

The Internal packaging, the pouch and patient labels are improperly labeled.

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 - 29147, 29148 & 29778

Product
OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is…
Recalling firm
OMNIlife science Inc.
Quantity
16 units
Distribution
US Nationwide Distribution - in the states of AZ, CA, CO, IL, FL & MA
Recall date
August 1, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls