| Date Initiated by Firm | December 01, 2020 |
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| Create Date | December 23, 2020 |
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| Recall Status1 |
Terminated 3 on July 08, 2022 |
| Recall Number | Z-0723-2021 |
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| Recall Event ID |
86923 |
| 510(K)Number | K093293 |
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| Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
| Product | Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty
Item Number: 185422 |
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| Code Information |
Lot Number: 098780 UDI Number: (01) 00880304482739 (17) 290501 (10) 098780 |
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
|
| For Additional Information Contact | 411 Technical Services
574-372-1687 |
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Manufacturer Reason
for Recall | Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure |
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FDA Determined
Cause 2 | Process control |
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| Action | .Zimmer Biomet issued Urgent Medical Device Recall letter issued on 12/1/20 to distributors with direct sales and/or fielded inventory via email and
traceable letter sent via FedEx. Hospitals with direct sales or current inventory will be notified via FedEx. Letter states reason for recall , health risk and action to take:
Distributors esponsibilities include: locating and removing the product in their territory, as well as identifying hospitals who have previously used the
product.
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. |
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| Quantity in Commerce | 21 units |
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| Distribution | Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands. |
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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 = JWH
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