Skeletal Kinetics recalls OsteoVation 5cc bone filler kits (part 390-2005, lot 1129957) due to mixing instructions mismatching product labels. No injuries reported.
A discrepancy was found between the Mixing Instruction Card and the Instructions for Use for the 5cc and 10 cc bone void filler kits. No customer complaints or reports of injury have been received.
Skeletal Kinetics is recalling OsteoVation 5cc bone filler kits with a specific part number and manufacturing lot because the mixing instructions don't match the product labels. This discrepancy could lead to improper use, but no injuries have been reported.
The mixing instructions on the product card differ from the official instructions for use. This mismatch could cause improper application of the bone filler, but no injuries have been reported.
Patients using OsteoVation 5cc bone filler kits with part number 390-2005 and manufacturing lot number 1129957 are affected. Medical professionals who administered these kits are most at risk of using incorrect instructions.
Check for part number 390-2005 and manufacturing lot number 1129957 on the product label. The product is sold as OsteoVation 5cc bone filler kits.
Look for part number 390-2005 and manufacturing lot number 1129957 on the product label.
No injuries have been reported, but the mixing instructions differ from the product labels, which could lead to improper use.
The official recall does not specify a remedy, so check the product label for part number 390-2005 and lot number 1129957 to confirm if it's affected.
Check the product label for part number 390-2005 and manufacturing lot number 1129957.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0866-2021 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-0866-2021 from Skeletal Kinetics. 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.
