Osteomed recalls OSTEOVATION 10 CC Impact Formula due to potential loss of setting characteristics after labeled shelf-life. Affected lots include 17051914, 1706050
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
Osteomed is recalling their OSTEOVATION 10 CC Impact Formula bone void filler kits because they may not maintain their setting properties for the labeled shelf life. This could lead to improper bone healing if used beyond the intended time frame.
The product may not maintain its setting characteristics for the labeled shelf-life duration. This means the bone filler could fail to properly harden as intended, potentially affecting bone healing.
Patients using the OSTEOVATION 10 CC Impact Formula for bone void fillers are affected. Those who have the specific lot numbers listed in the recall are most at risk.
Check the lot numbers on the product: 17051914, 17060106, 1127991, 1128827, 1132180, 1132479, 1134902, and 1142212. The product is used for bone void fillers that are replaced by bone during healing.
Look for the lot numbers listed: 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902, and 1142212.
The OSTEOVATION 10 CC Impact Formula is a bone void filler that is replaced by bone during the healing process.
Affected lot numbers include 17051914, 17060506, 1127991, 1128827, 1132180, 1132479, 1134902, and 1142212.
The product may not maintain its setting characteristics for the labeled shelf-life duration, which could affect bone healing.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2190-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2190-2020 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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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.
