Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328

FDA Recall Z-2479-2019 · Posted None

Recalling FirmOMNIlife science Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2019-07-23
Date Terminated2020-04-24
Product Quantity14 units

Reason for Recall

Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.

Firm Action

OMNIlife science, Inc. sent an Urgent Medical Device Recall letter, dated July 23rd, 2019. 1. Identify the affected product from inventory and hold (quarantine) the product. 2. Return product to Omni at 480 paramount drive, Raynham, MA 02767 3. Acknowledge this notice by retuning the acknowledgement and receipt form by fax to 508-819-3390 or email to [email protected] For further information contact Christina Rovaldi, Regulatory Affairs Manager at 774-226-1847 or 800-448-6664. Return the attached Acknowledgement form by FAX to 508-819-3390 or by email to [email protected]. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111572NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELSerf · 2011-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑