Valeris Medical recalls Apollo XT Suture Anchors (model XT-5515, lots 2358/2362/2363) due to incorrect material label. This could lead to improper use in shoulder, knee, and other repairs.
The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK.
Valeris Medical recalls specific Apollo XT Suture Anchors (model XT-5515, lots 2358, 2362, and 2363) because the label says they're made of titanium when they're actually made of PEEK. This mismatch could cause improper use during surgical repairs.
The label incorrectly states the anchor screw is titanium, but it's actually made of PEEK. This material difference could affect how the anchor functions during surgery, potentially leading to improper repair outcomes.
Surgical patients or medical professionals using the recalled Apollo XT Suture Anchors for shoulder, knee, or other joint repairs. Those with the specific model and lot numbers are most at risk.
Check for model number XT-5515 and lot numbers 2358, 2362, or 2363 on the product packaging. These anchors are used for shoulder, knee, and other joint repairs.
Look for model number XT-5515 and lot numbers 2358, 2362, or 2363 on the product packaging.
The label incorrectly states the anchor screw is titanium, but it's actually made of PEEK. This material difference could affect how the anchor functions during surgery.
Check the product label for model number XT-5515 and lot numbers 2358, 2362, or 2363. If you have these, contact Valeris Medical for guidance.
The recall is due to a material labeling error, not an immediate safety hazard. However, using the wrong material could lead to improper surgical outcomes.
We’ve drafted a message you can send Valeris Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2430-2018 — Valeris Medical Valeris Medical Hello, I own a Valeris Medical that is covered by recall Z-2430-2018 from Valeris Medical. 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.