FDA Medical Device Recalls (openFDA)
OMNIlife science Inc.: OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
- Recall number
- Z-2480-2019
- Recalling firm
- OMNIlife science Inc.
- Product
- OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
- Status
- Terminated
- Initiated
- 2019-07-23
- Posted
- not on file
- Terminated
- 2020-04-24
- Reason
- Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery.
- Root cause
- Nonconforming Material/Component
- 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 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. Company contact hours are Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time.
- Quantity
- 22 units
- Distribution
- US nationwide distribution to states of: IL, NY, OK, MD, AL, PA, CO, FL, and UT.
- Lot, serial or model codes
- LOT # 31740
- 510(k) numbers
- ["K111572"]
- PMA numbers
- not on file
- Product code
- LZO
- Firm FEI
- 3008342029
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28