Osteomed recalls OSTEOVATIONEX 5CC bone void filler kits with incorrect shelf-life. Products may not maintain setting characteristics after the labeled shelf-life.
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 OSTEOVATIONEX 5CC bone void filler kits because they may not maintain their setting properties for the labeled shelf-life. This could affect the healing process if the product fails to set properly.
The product may not maintain its setting characteristics for the labeled shelf-life. This could lead to improper bone healing if the filler fails to set correctly after application.
Patients using osteoporosis or bone repair treatments with the recalled OSTEOVATIONEX 5CC kits. Those with recent bone surgery are most at risk.
Check the lot numbers: 1128523, 1129958, 1135746, 1142073, 17071104, 17100404, and 1126669. The product is a bone void filler used in bone repair procedures.
Identify the lot number on the product label to see if it matches the recalled numbers: 1128523, 1129958, 1135746, 1142073, 17071104, 17100404, or 1126669.
The product may not maintain its setting characteristics for the labeled shelf-life, which could affect bone healing.
Check the lot number on the product label to see if it matches the recalled numbers. If it does, contact Osteomed for guidance.
The recall is for potential issues with the product's shelf-life, not a 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-2182-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2182-2020 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.
