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U.S. Department of Health and Human Services

Class 2 Device Recall OMNIlife science

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  Class 2 Device Recall OMNIlife science see related information
Date Initiated by Firm December 21, 2020
Create Date January 26, 2021
Recall Status1 Terminated 3 on June 10, 2021
Recall Number Z-0922-2021
Recall Event ID 87062
510(K)Number K111572  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
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
Code Information Lot Number: 28572
Recalling Firm/
Manufacturer		 OMNIlife science Inc.
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information Contact SAME
508-824-2444
Manufacturer 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
FDA Determined
Cause 2		 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 in Commerce 2 units
Distribution AL, ID, MD, NY, OK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = SERF
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