Skeletal Kinetics recalls SK SKAFFOLD IMPRESS 10CC bone filler kits that may not maintain setting characteristics, risking longer surgery or poor bone healing. Affected units have specific product numbers and 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 SK SKAFFOLD IMPRESS 10CC bone filler kits because they may not stay set for the labeled time. This could lead to longer surgery, incomplete bone healing, or complications like nonunion.
The bone filler kits may not maintain their setting properties over time, which can cause the filler to fail before the bone heals. This might require longer surgery, increase anesthesia time, or lead to incomplete bone formation, delayed healing, or nonunion.
Patients who received the SK SKAFFOLD IMPRESS 10CC bone filler kits during surgery are most at risk. The product is used for filling bone voids in extremities, spine, pelvis, or trauma injuries.
Check for product number SKAF-IM10 and unique device identifier (UDI) 813845020795. Affected units include lot numbers 1134223 and 1136544.
Verify the product number SKAF-IM10 and UDI 813845020795 to confirm if your kit is affected.
The product number is SKAF-IM10.
Lot numbers 1134223 and 1136544 are affected.
The bone filler kits may not maintain their setting characteristics for the labeled shelf-life, which could lead to longer surgery, incomplete bone healing, or complications like nonunion.
We’ve drafted a message you can send Skeletal Kinetics to request your refund or repair — edit it as you like.
Subject: Recall Z-2624-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2624-2020 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.
