Skeletal Kinetics recalls 10cc OsteoVation Bone Filler Kits (part 390-2010, lot 1130303) due to mismatched mixing instructions. 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 10cc OsteoVation Bone Filler Kits with part number 390-2010 and manufacturing lot 1130303 because the mixing instructions on the product don't match the official instructions. This mismatch could lead to incorrect use, but no injuries have been reported.
The mixing instructions on the product's card differ from the official instructions for use. This discrepancy might cause incorrect application, but the product is designed to be replaced by bone during healing.
Patients using the OsteoVation Bone Filler Kits for bone repair procedures are affected. Those who have the specific part number and manufacturing lot are most at risk.
Check for the product name 'OsteoVation, Inject, Bone Filler Kits 10cc' with part number 390-2010 and manufacturing lot 1130303. The label number is 12464.
Verify the part number (390-2010) and manufacturing lot (1130303) on the product label.
No injuries have been reported, but the mismatched instructions could lead to incorrect use.
The official recall does not specify a remedy, so check the product details and contact Skeletal Kinetics for further guidance.
Look for the product name 'OsteoVation, Inject, Bone Filler Kits 10cc' with part number 390-2010 and manufacturing lot 1130303.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-0867-2021 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-0867-2021 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.
