Skeletal Kinetics recalls OSTEOVATION EX 5CC Impact Formula for potential failure to maintain setting characteristics, risking longer surgery or incomplete bone healing. Affected units have specific lot numbers.
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 is recalling OSTEOVATION EX 5CC Impact Formula bone void filler kits because they may not stay set for the labeled time. This could lead to longer surgery, more anesthesia, or poor bone healing after use.
The bone void filler kits may not maintain their setting properties over time, which can cause the product to fail during healing. This might require longer surgical procedures, more anesthesia, or result in incomplete bone formation, delayed healing, or nonunion.
Patients undergoing bone surgery for voids or gaps in the skeletal system who used the recalled product. Surgeons and medical staff handling the product are at risk if they use the affected kits.
Check the product label for lot numbers: 1126985, 1128788, 1133246, or 1135313. The product is used for filling bone voids in surgeries for extremities, spine, pelvis, or traumatic injuries.
Look for lot numbers 1126985, 1128788, 1133246, or 1135313 on the packaging.
OSTEOVATION EX 5CC Impact Formula is used to fill bone voids or gaps in surgeries for extremities, spine, pelvis, or traumatic injuries.
The product may not maintain its setting characteristics, which could lead to longer surgery, more anesthesia, or incomplete bone healing.
Check the product label for lot numbers 1126985, 1128788, 1133246, or 1135313.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2613-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2613-2020 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.
