XTANT Medical recalls OsteoSelect DBM Putty 10.0cc syringes that contain 5.0cc instead of 10.00cc. This may cause improper bone graft treatment. Affected units have product code 359100 and lot numbers B180228-751 to B180228-779.
The firm received one customer complaint concerning three OsteoSelect Demineralized Bone Matrix (DBM) devices which contained 5.0cc of putty, instead of 10.00cc of putty as labeled.
XTANT Medical is recalling OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc syringes that contain 5.0cc instead of 10.00cc. Using the incorrect volume may lead to improper bone graft treatment and affect surgical outcomes.
The product contains 5.0cc of putty instead of the labeled 10.00cc. This incorrect volume may lead to improper bone graft treatment, potentially affecting surgical outcomes and healing.
Patients using this product for bone grafts or bone void fillers are affected. Surgeons and medical professionals who use the product for surgical procedures are most at risk.
Check for product code 359100 with lot numbers B180228-751 through B180228-779. The product expires by June 5, 2021, and is sold in 10.0cc syringes.
Verify the product code (359100) and lot numbers (B180228-751 to B180228-779) to confirm if your item is affected.
XTANT Medical received one customer complaint about three units containing 5.0cc instead of 10.00cc of putty.
The product should contain 10.00cc of putty, but some units contain only 5.0cc.
Look for product code 359100 with lot numbers B180228-751 through B180228-779.
We’ve drafted a message you can send XTANT Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1526-2020 — XTANT Medical XTANT Medical Hello, I own a XTANT Medical that is covered by recall Z-1526-2020 from XTANT Medical. 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.
