Osteomed recalls OSTEOVATIONEX 3CC ImpactFormula due to potential loss of setting characteristics within labeled shelf-life. Affected lots include 17102713, 1156491, 17051907, 1136327, 1126984.
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 OSTEOVATIONEX 3CC ImpactFormula 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 after the shelf life expires.
The product may not retain its setting characteristics for the labeled shelf life. This means the bone filler could fail to properly fill bone voids during healing if used after the expiration date.
Patients using OSTEOVATIONEX 3CC ImpactFormula for bone void fillers are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check the lot numbers on the product: 17102713, 1156491, 17051907, 1136327, and 1126984. The product is a bone void filler used in medical procedures.
Look for the lot numbers listed: 17102713, 1156491, 17051907, 1136327, and 1126984.
The OSTEOVATIONEX 3CC ImpactFormula is a bone void filler used in medical procedures to replace bone during healing.
The product may not maintain its setting characteristics for the labeled shelf life, which could lead to improper bone healing if used after expiration.
Check the lot numbers on the product: 17102713, 1156491, 17051907, 1136327, and 1126984.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2186-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2186-2020 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.
