Paragon 28 recalls JAWS Nitinol Staple System kits for foot bone repairs due to missing drill guide in some models. Affected kits include specific part numbers and production lots. Consumers should check their kit details and contact Paragon 28 for guidance.
Missing drill guide as stated in the package.
Paragon 28 is recalling specific JAWS Nitinol Staple System kits used for foot bone repairs because they may be missing the drill guide. This could lead to improper use during surgery. Affected kits have specific part numbers and production lots listed in the recall.
The kits are designed for precise bone fixation but may be missing the drill guide, which is critical for proper surgical placement. Without this guide, the risk of improper bone alignment or damage to surrounding tissues increases.
Orthopedic surgeons and medical professionals who use these kits for foot bone repairs are most at risk. Patients receiving these procedures may also be affected if the kits are used without the drill guide.
Check the part number and production lot on the kit. Affected kits include specific models like P71-008-0808-S (8mm) and P71-108-0808-S (angled) with lots from 260315217A to 260326217G.
Look for the part number and production lot on the kit to determine if it is affected.
The recall is due to the missing drill guide in some kits, which is critical for proper surgical placement during foot bone repairs.
Affected kits include specific part numbers and production lots: P71-008-0808-S (8mm), P71-108-0808-S (angled), P71-010-1010-S (10mm), and P71-110-1010-S (angled) with lots from 260315217A to 260326217G.
The recall does not require immediate stop use; affected kits should be checked for the missing drill guide before use.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-2261-2018 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-2261-2018 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.
