Osteomed recalls OSTEOVATION RMX 5CC bone void filler kits with incorrect shelf-life. Products may not maintain setting characteristics for labeled duration. Affected lots: 1125793, 1129602, 1132492, 1132347, 1134448, 1137064, 1142080.
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 certain OSTEOVATION RMX 5CC bone void filler kits because they have an incorrect shelf-life. This means the products may not set properly over time, potentially affecting bone healing. Consumers should check the lot numbers listed in the recall notice.
The bone void filler kits have a shelf-life that doesn't match the actual setting characteristics. If the product doesn't set properly, it could delay bone healing or cause complications during the recovery process.
Patients using osteoporosis or bone repair treatments with the recalled OSTEOVATION RMX 5CC kits. Those with the specific lot numbers listed are most at risk.
Check the lot numbers on the product: 1125793, 1129602, 1132492, 1132347, 1134448, 1137064, or 1142080. The product is labeled as OSTEOVATION RMX Injectable BVF 5CC.
Look for the lot numbers listed: 1125793, 1129602, 1132492, 1132347, 1134448, 1137064, or 1142080.
The product has an incorrect shelf-life, which means it may not maintain its setting characteristics for the labeled duration.
Check the lot number on the product. If it matches the listed numbers, contact Osteomed for instructions.
The recall is for potential issues with bone healing, but the hazard is not described as causing serious injury in normal use.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2189-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2189-2020 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.