IsoTis recalls OsteoCove and Cove Putty products due to hydration issues making the putty less cohesive and moldable than intended. Affected items have specific reference numbers and expiration dates.
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
IsoTis is recalling OsteoCove Putty and Cove Putty products because they may become less cohesive and moldable due to a hydration issue with the polymer. This could affect the product's effectiveness for medical use.
The putty may become less cohesive and moldable than intended because of a hydration issue with the polymer. This could lead to the product not functioning as expected for medical applications.
People who own or use OsteoCove Putty or Cove Putty products with the specified reference numbers and expiration dates are affected. Medical users are most at risk due to potential impact on product performance.
Check for reference numbers: OsteoCove Putty REF 56920013 or Cove Putty REF 02-9200-01. Products with specific expiration dates listed in the recall notice are affected.
Review the reference number and expiration date on the product to confirm if it matches the recalled items.
The product may become less cohesive and moldable than intended due to a hydration issue with the polymer.
The recall does not specify a remedy, so check the product details to see if it matches the recalled items.
The recall indicates a potential issue with product performance, but no serious injury risk is mentioned.
We’ve drafted a message you can send IsoTis to request your refund or repair — edit it as you like.
Subject: Recall Z-0919-2025 — IsoTis IsoTis Hello, I own a IsoTis that is covered by recall Z-0919-2025 from IsoTis. 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.
