Recall Z-0922-2021 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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
| Date | Dec 21, 2020 |
| Status | Terminated |
| 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 o |
| Quantity | 2 units |
| Distribution | AL, ID, MD, NY, OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111572 | NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL Serf, Aug 29, 2011 |