| Date Initiated by Firm | July 10, 2026 |
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| Date Posted | August 14, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2972-2026 |
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| Recall Event ID |
99504 |
| Product Classification |
Bone Wedge - Product Code PLF
|
| Product | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant |
|---|
| Code Information |
Lot Number AOCIA6123 |
| FEI Number |
3008650117
|
Recalling Firm/
Manufacturer |
Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062
|
| For Additional Information Contact | N/A
+1-888-7281888 |
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Manufacturer Reason
for Recall | Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Paragon 28 issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/14/2026 via FedEx 2nd day. The notice explained the issue, potential risk, and requested the following:
Distributors:
"Your 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. Mark RECALL on the outside of the returned cartons.
4. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility.
5. If you have further questions or concerns after reviewing this notice, please call 888-728-1888. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com."
Risk Manager:
"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 Paragon 28 sales representative and quarantine all affected product. Your Paragon 28 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. Retai |
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| Quantity in Commerce | 1 unit |
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| Distribution | US Nationwide distribution i the state of MT. |
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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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