Osteomed recalls OSTEOVATION 5CC ImpactFormula due to potential loss of setting characteristics within labeled shelf-life. Affected products have specific lot numbers.
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 5CC ImpactFormula bone void fillers 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 duration. This means the bone filler could fail to set correctly, potentially affecting the healing process.
Patients using OSTEOVATION 5CC ImpactFormula for bone void fillers are most at risk if the product fails to set properly during healing. The recall affects specific lot numbers.
Check the product label for lot numbers: 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043, and 1142210.
Look for the lot numbers listed: 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043, and 1142210.
The OSTEOVATION 5CC ImpactFormula is a bone void filler that is replaced by bone during the healing process.
Lot numbers 17060509, 17102710, 17040533, 17051911, 1126986, 1128789, 1134232, 1136330, 1144043, and 1142210.
The recall record states the remedy is null, meaning no specific action is required beyond checking the lot number.
We’ve drafted a message you can send Osteomed to request your refund or repair — edit it as you like.
Subject: Recall Z-2188-2020 — Osteomed Osteomed Hello, I own a Osteomed that is covered by recall Z-2188-2020 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.
