FDA Medical Device Recalls (openFDA)
Paragon 28, Inc.: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Recall number
- Z-2971-2026
- Recalling firm
- Paragon 28, Inc.
- Product
- Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Status
- Open, Classified
- Initiated
- 2026-07-10
- Posted
- 2026-08-14
- Terminated
- not on file
- Reason
- Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
- Root cause
- Under Investigation by firm
- 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
- Quantity
- 1
- Distribution
- US Nationwide distribution i the state of MT.
- Lot, serial or model codes
- Lot Number AOCIA6123
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PLF
- Firm FEI
- 3008650117
- Firm city
- Englewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28