Skeletal Kinetics recalls ACUMED IMPACT 5CC bone void filler kits with lot numbers 1126150, 1128790, 1136332. These kits may not maintain setting characteristics, increasing surgery time or causing incomplete bone healing.
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 ACUMED IMPACT 5CC bone void filler kits that may not hold their shape for the labeled time. This could lead to longer surgery, more anesthesia, or poor bone healing after the procedure.
The bone void filler kits may not stay set for the full time the label says. This could mean the surgery takes longer, more anesthesia is needed, or the bone doesn't heal properly.
Patients who received ACUMED IMPACT 5CC bone void filler kits with lot numbers 1126150, 1128790, or 1136332 during surgery are most at risk. These kits are used to fill bone gaps in surgeries for extremities, spine, or pelvis.
Check the lot number on the kit: 1126150, 1128790, or 1136332. These kits are used in surgeries to fill bone gaps in extremities, spine, or pelvis.
Look for lot numbers 1126150, 1128790, or 1136332 on the ACUMED IMPACT 5CC bone void filler kit.
Product number: 65-0105-S
Lot numbers: 1126150, 1128790, 1136332
The kits may not maintain their setting characteristics for the labeled shelf-life, which could increase surgery time or cause incomplete bone 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-2596-2020 — Skeletal Kinetics Skeletal Kinetics Hello, I own a Skeletal Kinetics that is covered by recall Z-2596-2020 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.
