Osteomed recalls OSTEOVATION 10CC bone void filler kits with incorrect shelf-life. Products may not maintain setting characteristics for labeled duration, risking improper healing.
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 OSTEOVATION 10CC injectable bone void filler kits because they may not maintain their setting properties for the labeled shelf life. This could lead to improper healing if used beyond the intended time frame.
The product's shelf-life is incorrect, meaning it may not set properly within the labeled time frame. This could cause the filler to fail to maintain its structure during healing, potentially leading to improper bone fusion.
Patients using OSTEOVATION 10CC bone void filler kits for bone healing are most at risk if they use the product after the labeled shelf life expires.
Check the product label for the lot numbers: 1127160, 1127031, 1130303, 1138055, 1139832, or 1142076. The product is a bone void filler used in medical procedures to replace bone during healing.
Look for the lot numbers listed: 1127160, 1127031, 1130303, 1138055, 1139832, or 1142076 on the product label.
The product may not maintain its setting characteristics for the labeled shelf-life duration, which could affect healing.
Check the lot number on the product label. If it matches the listed numbers, contact Osteomed for guidance.
The recall is for potential issues with the product's shelf-life, not an immediate risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2184-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2184-2020 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.
