Zavation recalls 11-gauge bipedicular bone access kits with drill (REF VCF-DDBAK-11) due to potential inadequate sterilization. Affected lots: 20071774, 19123262.
Products distributed as sterile may not have been adequately sterilized
Zavation is recalling its 11-gauge bipedicular bone access kits for orthopedic procedures because some kits may not have been properly sterilized. This could lead to infections or other complications if used in medical procedures.
The kits may not have been adequately sterilized during manufacturing, which could lead to infections or other complications if used in medical procedures. This is a risk specific to surgical environments where sterile conditions are critical.
Orthopedic surgeons and medical professionals who use the Zavation bone access kits for spinal or orthopedic procedures. Patients receiving these kits are at risk if the kits were not properly sterilized.
Check for the product reference number VCF-DDBAK-11 on the kit. Affected lots are 2007177: 20071774 and 19123262.
Look for the lot numbers 20071774 or 19123262 on the kit packaging.
The recall indicates potential inadequate sterilization, so affected kits should not be used until the remedy is applied. However, the remedy is not specified in the recall notice.
Check the lot number on the kit. If it matches 20071774 or 19123262, contact Zavation for instructions.
The recall notice does not specify a replacement process or remedy.
We’ve drafted a message you can send Zavation to request your refund or repair — edit it as you like.
Subject: Recall Z-1729-2021 — Zavation Zavation Hello, I own a Zavation that is covered by recall Z-1729-2021 from Zavation. 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.
