OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component
Summary
The FDA issued a Class II for OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is in by OmniLife Science. Reason: 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.
Details
Source
Device Recall
External ID
Z-0237-2022
Action Date
2021-11-24
Status
Terminated
Category
device
Product Description
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 replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
Lot/Code Info: UDI 00841690102496 Lot 38933
Quantity Affected: 7
Reason for Recall
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.
Distribution
US Distribution to states of: Colorado and Virginia.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-01
Company
Raynham, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OmniLife Science) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OmniLife Science have FDA actions?
This is the only FDA action we have on record for OmniLife Science in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0237-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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