Spinal Elements recalls Piranha Screw 4.0 x 12mm used in surgical plates. Some screws marked as 12mm actually measure 14mm, risking incorrect spinal fixation. Affected patients should contact for details.
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
Spinal Elements is recalling Piranha Screw 4.0 x 12mm used in spinal surgery systems because some screws marked as 12mm actually measure 14mm. This could lead to improper spinal fixation during surgery, potentially causing complications.
The screws may be incorrectly marked as 12mm but actually measure 14mm. This mismatch could lead to improper spinal fixation during surgery, potentially causing complications like misalignment or instability.
Patients who received the Piranha Surgical Plate System with this screw model are affected. Surgeons and medical staff using the system are most at risk during procedures.
Check for the part number CSF-40-12 and lot number 132635 on the screw packaging. The screws are used in the Piranha Surgical Plate System for cervical spine stabilization.
Reach out to Spinal Elements directly for specific recall instructions and assistance with the affected product.
The recall is due to potential incorrect marking and color identification, where some screws marked as 12mm actually measure 14mm.
Using screws with the wrong size could lead to improper spinal fixation during surgery, potentially causing complications.
Look for part number CSF-40-12 and lot number 132635 on the screw packaging.
We’ve drafted a message you can send Spinal Elements to request your refund or repair — edit it as you like.
Subject: Recall Z-0239-2018 — Spinal Elements Spinal Elements Hello, I own a Spinal Elements that is covered by recall Z-0239-2018 from Spinal Elements. 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.
