Back 2 Basics recalls Dymaxeon 5.5 Curved Rods (Model 06.6441B) that may contain 100mm rods instead of 110mm. This could cause improper spinal fixation. Affected units sold with Lot 779C4.
Packages labeled as containing 110mm rods may contain 100mm rods.
Back 2 Basics is recalling Dymaxeon 5.5 Curved Rods (Model 06.6441B) because some packages labeled as 110mm may actually contain 100mm rods. Using the wrong size could lead to improper spinal stabilization and potential complications during spinal surgery.
The recall addresses a packaging error where some 110mm rod packages may contain 100mm rods instead. Using the wrong size could lead to improper spinal stabilization during fusion surgery, potentially causing complications like misalignment or inadequate fusion.
Patients who received the Dymaxeon Spine System (Model 06.6441B, Lot 779C4) for spinal fusion procedures are most at risk. Healthcare providers using this product in surgeries may also be affected.
Check for the model number 06.6441B on the product packaging. The affected units were sold with Lot 779C4. The product is a Dymaxeon 5.5 Curved Rod (Yellow) that is 110mm long.
Check the model number on the packaging to confirm it is 06.6441B.
The recall is due to a packaging error where some packages labeled as containing 110mm rods may actually contain 100mm rods instead.
Using the wrong size (100mm instead of 110mm) could lead to improper spinal stabilization during fusion surgery, potentially causing complications like misalignment or inadequate fusion.
Check for the model number 06.6441B and Lot 779C4 on the packaging. The affected product is a Dymaxeon 5.5 Curved Rod (Yellow) that is 110mm long.
We’ve drafted a message you can send Back 2 Basics to request your refund or repair — edit it as you like.
Subject: Recall Z-2881-2018 — Back 2 Basics Back 2 Basics Hello, I own a Back 2 Basics that is covered by recall Z-2881-2018 from Back 2 Basics. 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.
