Recall Z-0921-2021— OMNIlife science Inc.

Name: FDA recall Z-0921-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-21

Class II · Terminated

Class II FDA medical device recall by OMNIlife science Inc., initiated 2020-12-21, terminated 2021-06-10. It names one FDA 510(k) clearance: K111572. Product: SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728. 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.

Recalling firm: OMNIlife science Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Terminated: 2021-06-10
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K111572 — NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELSerf·cleared 2011-08-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.