IsoTis OsteoCove Putty Recall: Hydration Issue Causes Poor Cohesion
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.
Lower-risk recall
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/53383-isotis-osteocove-putty-recall-hydration-issue-causes-poor-cohesion.
Source Summary by GovInfoNow · govinfonow.com/recall/53383-isotis-osteocove-putty-recall-hydration-issue-causes-poor-cohesion · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0919-2025
Cite this page
“IsoTis OsteoCove Putty Recall: Hydration Issue Causes Poor Cohesion.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53383-isotis-osteocove-putty-recall-hydration-issue-causes-poor-cohesion. Based on FDA recall #Z-0919-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0919-2025%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
IsoTis- Category
Medical device
What to do — step by step
Check Product Details
Review the reference number and expiration date on the product to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
FDA distribution: “US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Maryland, Minnesota, Mississippi, Nevada, North Carolina, Ohio, Oklahoma, Texas.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there any safety risks?
The recall indicates a potential issue with product performance, but no serious injury risk is mentioned.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-0919-2025 (November 27, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0919-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.