| Date Initiated by Firm | June 02, 2021 |
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| Create Date | August 12, 2021 |
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| Recall Status1 |
Terminated 3 on July 06, 2022 |
| Recall Number | Z-2263-2021 |
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| Recall Event ID |
88304 |
| 510(K)Number | K090757 |
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| Product Classification |
Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
|
| Product | Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM
Item Number: 11-301311 |
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| Code Information |
Lot Numbers/UDI :
678930 (01)00880304474086(17)310315(10)678930
880200 (01)00880304474086(17)310427(10)880200
|
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact | 411 Technical Services Inc.
574-371-3071 |
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Manufacturer Reason
for Recall | Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion
and device failure in vivo leading to surgical intervention |
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FDA Determined
Cause 2 | Process control |
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| Action | Zimmer Biomet issued Urgent Medical Device Notification Letter on 6/2/21 to Distributors/ Risk Managers/Surgeons, stated reason for recall, health risk and action to take:
Risk Manager Responsibilities:
1. Review this notification and ensure that affected personnel are aware of the contents.
2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation.
4. Complete Attachment 1 Certificate of Acknowledgement and send to
CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility.
5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours
will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency.
Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Surgeon Responsibilities:
1. Review this notification for awareness of the contents.
2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your
existing follow-up schedule.
3. Complete Attachment 1 Certificate of Acknowledgement and send to
CorporateQuality.PostMarket@zimmerbiomet.com.
4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your
facilitys documentation.
5. If you have further questions or concerns after reviewing this notice, please ca |
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| Quantity in Commerce | 22 units |
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| Distribution | US Nationwide distribution. |
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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 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 = KWA
|
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