Osteomed recalls OSTEOVATION RMX 10 CC Injectable due to potential shelf-life issues affecting bone void filler setting characteristics.
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 RMX 10 CC Injectable bone void filler kits because the shelf-life may be incorrect. This could mean the product doesn't maintain its setting characteristics for the labeled time period, potentially affecting healing.
The product may not maintain its setting characteristics for the labeled shelf-life duration. This could lead to improper healing if the filler doesn't set correctly after application.
Patients using this bone void filler for medical procedures are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for the lot numbers: 1127902, 1129603, 1132560, 1134444, 1137073, 1141342, and 1142084. The product is used for bone void fillers in medical procedures.
Look for the lot numbers listed: 1127902, 1129603, 1132560, 1134444, 1137073, 1141342, and 1142084.
The OSTEOVATION RMX 10 CC Injectable is a bone void filler that is replaced by bone during the healing process.
Lot numbers 1127902, 1129603, 1132560, 1134444, 1137073, 1141342, and 1142084.
The recall record does not specify a remedy.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2191-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2191-2020 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.
