ClearanceBrief
Recall Z-2480-2019 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

OMNIlife science Inc.

OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128

DateJul 23, 2019
StatusTerminated
ReasonAcetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
Root causeNonconforming Material/Component
ActionOMNIlife 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 Omni-cs@coringroup.com 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 Omnics@coringroup.com. Comp
Quantity22 units
DistributionUS nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K111572NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL
Serf, Aug 29, 2011