Skeletal Kinetics recalls OSTEOVATION 5CC Impact Formula for possible improper setting, risking longer surgery or bone healing issues. Affected lots: 17040533, 17051911, etc.
Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Skeletal Kinetics recalls OSTEOVATION 5CC Impact Formula bone filler kits that may not set properly over time. This could lead to longer surgery, complications, or poor bone healing. Consumers should check the lot numbers listed in the recall notice.
The bone filler may not maintain its setting characteristics for the labeled shelf life, which could lead to longer surgical times or incomplete bone healing. This might result in delayed union or nonunion of the bone.
Patients who have received OSTEOVATION 5CC Impact Formula for bone voids or gaps, particularly those undergoing surgery for skeletal defects. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for lot numbers: 17040533, 17051911, 17060509, 17102710, 1126986, 1128789, 1134232, 1136330, 1144043, 1142210. The product is used for filling bone voids or gaps in the skeletal system.
Look for lot numbers on the product label: 17040533, 17051911, 17060509, 17102710, 1126986, 1128789, 1134232, 1136330, 1144043, 1142210.
The recall states that the product may not maintain its setting characteristics, which could lead to longer surgery or poor bone healing. It is not recommended for use in the affected lots.
Check the product label for the lot numbers listed. If you have one of the affected lots, contact Skeletal Kinetics for guidance.
The product may not set properly over time, which could cause longer surgery, incomplete bone formation, or delayed healing.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2619-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2619-2020 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.
