FDA Medical Device Recalls (openFDA)
OMNIlife science Inc.: SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
- Recall number
- Z-0922-2021
- Recalling firm
- OMNIlife science Inc.
- Product
- SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
- Status
- Terminated
- Initiated
- 2020-12-21
- Posted
- not on file
- Terminated
- 2021-06-10
- Reason
- Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery
- Root cause
- Under Investigation by firm
- Action
- Omni Life Initial communication was sent by email via a quarantine form on 12/09/2020. On 12/22/20 a notification packet detailing parameters of recall sent via email and overnight mail. Acknowledgement of receipt is requested. Actions to be taken by the Customer/User " Immediately quarantine lots 28413, 28624 and 28572 " Return Product to OMNI at 480 Paramount Drive, Raynham MA 02767 " This advisory notice only includes the lots identified above. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form by FAX to 508-819-3390 or my email to Omni-cs@coringroup.com.
- Quantity
- 2 units
- Distribution
- AL, ID, MD, NY, OK
- Lot, serial or model codes
- Lot Number: 28572
- 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