Paragon 28 recalls HammerTube Implant 2.75mm cannulated (sterile) due to missing titanium coating. Affected units have specific part numbers and lot numbers. Consumers should contact for details.
Due to Titanium plasma coating not present implant.
Paragon 28 is recalling HammerTube Implant surgical devices that lack a required titanium coating. This could lead to improper healing or infection risks if used without the coating.
The implant requires a titanium coating for proper biocompatibility and integration with the body. Without this coating, it may cause infection, poor healing, or rejection.
Surgical patients who received this specific implant model during the listed production period. Patients using the implant without the titanium coating are at risk.
Check for part number P40-002-0275-S and lot number 26010822202 on the implant packaging or label. The implant is sterile and cannulated.
Reach out to Paragon 28 directly for specific guidance on affected units and next steps.
The recall states the implant lacks a required titanium coating, which could lead to infection or poor healing. It is not safe without this coating.
Check for part number P40-002-0275-S and lot number 26010822202 on the implant packaging or label.
Contact Paragon 28 directly for specific guidance on affected units and next steps.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-1468-2022 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-1468-2022 from Paragon 28. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.