Synthes recalls specific end rings for spinal surgery due to incorrect labeling as a general medical device instead of specially controlled medical device. This affects certain lot numbers of the 22mm x 28mm lateral/anterior implants used in spinal fusion procedures.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Synthes is recalling specific spinal implants (end rings) that were incorrectly labeled as general medical devices instead of specially controlled medical devices. This labeling error could lead to improper regulatory oversight and potential safety risks during surgical procedures.
The implants were incorrectly labeled as a general medical device rather than a specially controlled medical device. This labeling error could result in improper regulatory oversight and potentially unsafe use during surgical procedures.
Surgeons and medical facilities that use the recalled end rings for spinal fusion procedures are affected. Patients receiving these implants during surgery are at risk if the labeling error impacts their treatment.
Check for the product number 495-396 on the end rings. Look for lot numbers 17P4887 or 32P3937. These end rings are used for spinal fusion procedures in the cervical, thoracic, and lumbar spine.
Look for the product number 495-396 and lot numbers 17P4887 or 32P3937 on the end rings.
The recalled product is the Synthes End Ring 22mm X 28mm Lateral or Anterior/0 Deg (TI) with product number 495-396.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device on the statutory label.
The recall record does not specify a remedy, so no action is required beyond checking the product label for the specific lot numbers.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0413-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0413-2021 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.
