SPINEART SA recalls PERLA cannulated fenestrated polyaxial screws (model MPF-PS 6:45 40-S) due to possible incorrect labeling. Affected units may have wrong specifications.
Cannulated fenestrated polyaxial screws may be incorrectly labeled
SPINEART SA is recalling PERLA cannulated fenestrated polyaxial screws (model MPF-PS 65 40-S) because they may be incorrectly labeled. This could lead to improper use in medical procedures.
Incorrect labeling could mean the screws don't match the intended specifications for spinal surgery. This might lead to improper fixation or complications during procedures.
Medical professionals using these screws for spinal surgery are most at risk. Patients receiving the screws during surgery may be affected if the labeling is incorrect.
Check for the model number MPF-PS 65 40-S on the screw packaging or label. The lot number 8-4528 is also associated with this recall.
Verify the model number and lot number on the screw packaging or label.
The screws may be incorrectly labeled, which could lead to improper use in spinal surgery.
Model MPF-PS 65 40-S with lot number 8-4528.
No, but you should check the labeling to ensure it matches the correct specifications.
We’ve drafted a message you can send PERLA to request your refund or repair — edit it as you like.
Subject: Recall Z-2279-2025 — PERLA PERLA Hello, I own a PERLA that is covered by recall Z-2279-2025 from PERLA. 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.
