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Class 2 Device Recall Femoral Resurfacing Cup, |
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Date Initiated by Firm |
May 30, 2023 |
Date Posted |
April 08, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1498-2024 |
Recall Event ID |
94278 |
Product Classification |
Prosthesis, hip, pelvifemoral resurfacing, metal/polymer - Product Code KXB
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Product |
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
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Code Information |
UDI/REF Number:
00814193025708/01-03-0042;
00814193025678/01-03-0044;
00814193025692/01-03-0045;
00814193025685/01-03-0047;
00814193025654/01-03-0049;
00814193025661/01-03-0051;
00814193025753/01-03-0052;
REF Number/Lot Number:
01-03-0044 01030044K2NN656,
01-03-0044 01030044K3NN736,
01-03-0045 01030045LNN657,
01-03-0045 01030045MNN670,
01-03-0045 01030045N1NN694,
01-03-0045 01030045NNN694,
01-03-0045 01030045QNN733,
01-03-0045 01030045RNN742,
01-03-0047 01030047LNN657,
01-03-0047 01030047L4NN662,
01-03-0047 01030047MNN674,
01-03-0047 01030047N1NN689,
01-03-0047 01030047NNN689,
01-03-0047 01030047QNN733,
01-03-0049 01030049MNN662,
01-03-0049 01030049M8NN670,
01-03-0049 01030049QNN687,
01-03-0049 01030049R1NN724,
01-03-0049 01030049RNN725,
01-03-0049 01030049UNN732,
01-03-0049 01030049UNN733,
01-03-0049 01030049NNN736,
01-03-0051 01030051K3NN658,
01-03-0051 01030051K4NN666,
01-03-0051 01030051K4NN667,
01-03-0051 01030051KNN673,
01-03-0051 01030051LNN685,
01-03-0051 01030051M1NN694,
01-03-0051 01030051M3NN694,
01-03-0051 01030051MNN694,
01-03-0051 01030051M4NN697,
01-03-0051 01030051NNN731,
01-03-0051 01030051N1NN732,
01-03-0051 01030051N1NN733,
01-03-0051 01030051Q1NN739,
01-03-0051 01030051QNN742,
01-03-0052 01030052JNN663,
01-03-0052 01030052KNN669,
01-03-0052 01030052GNN685,
01-03-0052 01030052LNN694,
01-03-0052 01030052L1NN694,
01-03-0052 01030052L2NN694,
01-03-0052 01030052L3NN694,
01-03-0052 01030052MNN733.
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Recalling Firm/ Manufacturer |
Synovo Production 1501 N Harbor Blvd Ste 209 Fullerton CA 92835-3803
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For Additional Information Contact |
customer service 800-410-4240
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Manufacturer Reason for Recall |
Medical device components were marketed without FDA clearance
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FDA Determined Cause 2 |
No Marketing Application |
Action |
On March 21, 2024, Synovo Production issued a "Urgent Medical Device Recall" notification to affected consignees. Synovo asked consignees to take the following actions:
1. The affected devices should not be used in patients at this time; therefore, please quarantine and return all Acetabular Fixation Cups, Acetabular Bearings, and Femoral Resurfacing Cups. Please complete the enclosed recall response form detailing the affected current products that are in your possession. Be sure to follow the outlined steps:
1a) Segregate and quarantine the products;
2b) Please contact us with the return shipment carton quantity as well as the weight. We will provide a return label for shipping;
3c) Notify your consignees others within your network that may have received these devices and disseminate to them a copy of this communication. instruct them to identify and segregate any affected product from their inventory for return to Synovo.
2. Work with consignees to determine if any of the potential risks identified above from the modified devices have been experienced. Report this adverse event information directly to the manufacturer and/or FDA by completing the MedWatch Voluntary Reporting Form.
3. For any additional details see recall notification. |
Quantity in Commerce |
496 units |
Distribution |
US Nationwide distribution in the state of WA.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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