Synthes recalls 3.0MM locking screw implants due to incorrect labeling as a general medical device instead of specially controlled medical device. This may affect spinal surgery safety.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes is recalling a specific spinal implant screw product because it was incorrectly labeled as a general medical device rather than a specially controlled medical device. This labeling error could impact surgical safety and regulatory compliance.
The product was incorrectly labeled as a 'general medical device' instead of a 'specially controlled medical device' on its statutory label. This mislabeling could lead to improper regulatory handling or surgical procedures if the device is not managed according to the required controls for specialized implants.
Surgeons and hospitals using the recalled 3.0MM locking screw implants for spinal procedures are likely affected. Patients receiving these implants during surgery may be at risk if the labeling error impacts device handling or regulatory requirements.
Check for the product name '3.0MM LOCKING SCREW LOW PROFILE (TI)' with product number 495-491. The recall includes lot numbers 13L2504 and M22 for spinal implants used in cervical, thoracic, and lumbar spine procedures.
Look for the product number 495-491 on the implant package or device itself.
The product was incorrectly labeled as a 'general medical device' instead of a 'specially controlled medical device' on its statutory label.
The recall record does not specify a remedy, so no action is required beyond checking the product label.
The recall affects hospitals and surgeons using the specific product number 495-491 for spinal procedures.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0417-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0417-2021 from Synthes. 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.
