Product Wiki · Recalls · U.S. FDA — Device Enforcement

OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip… — recall Z-0237-2022

U.S. FDA — Device Enforcement · United States · 2021-10-01 · Class II

As described by U.S. FDA — Device Enforcement: 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.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0237-2022
Date of alert
2021-10-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
OmniLife Science
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Distribution to states of: Colorado and Virginia.
Barcode (EAN/GTIN)
00841690102496
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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