| Date Initiated by Firm | September 09, 2025 |
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| Date Posted | September 23, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2619-2025 |
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| Recall Event ID |
97570 |
| 510(K)Number | K110879 |
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| Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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| Product | Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 |
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| Code Information |
UDI-DI: 00880304520950; Lot Number 0002713620
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Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
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| For Additional Information Contact | 411 Technical Services
574-3713071 |
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Manufacturer Reason
for Recall | The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 9/9/25 was sent to customers.
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 recall notice 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 facility s 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.
Distributor Responsibilities:
1. Review this notification and ensure that affected team members are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.
a. Complete Attachment 1 Inventory Return Certification Form for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products available to return in your territory.
b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing.
c. M |
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| Quantity in Commerce | 40 |
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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 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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| 510(K) Database | 510(K)s with Product Code = MBI
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