Paragon 28 recalls 10mm wedge implant kits labeled as 12mm to prevent surgical errors. The mislabeling risks improper surgical site preparation and delays in procedures.
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Paragon 28 is recalling 10mm wedge implant kits that are incorrectly labeled as 12mm. Using these kits could cause surgical site preparation errors and delay procedures.
The kit is labeled as 12mm but is actually 10mm. This size mismatch could lead to improper surgical site preparation, causing delays in surgery.
Surgical teams using the recalled implant kits are affected. The risk is highest for procedures requiring precise 10mm implants.
Check for the product name 'P28 Titan 3-D Wedge, Evans, Large, 10 mm, sterile' with the reference number P03-EVN-1010-S. The kit is labeled as 12mm but is a 10mm size.
Verify the size label on the kit; it should read 10mm, not 12mm.
The wedge implant kit is permanently mislabeled as 12mm but is actually 10mm, which could cause surgical site preparation errors.
Check the label to confirm it's a 10mm size. If mislabeled, contact Paragon 28 for guidance.
The recall is for potential surgical delays, not direct injury risks. The hazard is low risk as it only affects procedure timing.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-0662-2020 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-0662-2020 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.
