| Class 2 Device Recall OMNIlife science | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LZO
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