OMNI K2 Hip Stem recall
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip…
Why was OMNI K2 Hip Stem recalled?
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
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?
UDI 00841690102496 Lot 38933
- Product
- OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip…
- Recalling firm
- OmniLife Science
- Quantity
- 7
- Distribution
- US Distribution to states of: Colorado and Virginia.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)