Osteomed OSTEOVATION 5CC Formula May Not Set Properly After Shelf-Life

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Recalling firmOsteomed, LLC3885 Arapaho Rd, N/A · Addison, TX 75001-4314

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Osteomed is recalling OSTEOVATION 5CC inject formula because it may not maintain its setting characteristics for the labeled shelf-life. This could affect bone healing if used improperly.

Why it’s dangerous

The product's shelf-life is incorrect, meaning it might not set properly over time. This could lead to improper bone healing if the product fails to maintain its structure during the healing process.

Who’s affected

People who use OSTEOVATION 5CC for bone void fillers, especially those with medical procedures involving bone healing. Patients using the product are most at risk.

How to tell if you have this one

Check the product label for lot numbers: 17040525, 1127972, 17071105, 1129957, or 1135744. The product is used for bone void fillers in medical procedures.

Brand
Osteomed
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers on the product label: 17040525, 1127972, 17071105, 1129957, or 1135744.

✎ GovInfoNow

Questions people ask

What is the product used for?

The OSTEOVATION 5CC inject formula is used as a bone void filler that is replaced by bone during healing.

Why is this product being recalled?

The product has an incorrect shelf-life, which may cause it to not maintain its setting characteristics for the labeled duration.

How can I tell if I have the recalled product?

Check the product label for lot numbers: 17040525, 1127972, 17071105, 1129957, or 1135744.

Take action

Contact Osteomed

We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2183-2020 — Osteomed Osteomed

Hello,

I own a Osteomed that is covered by recall Z-2183-2020 from Osteomed.

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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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-2183-2020 (April 2, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2183-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

Osteomed, LLC recalls OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product Usage: The product provides a bone void

Lower-risk recall