Synthes recalls END RING 12MM DIA/0 DEG (TI) product due to incorrect labeling as a general medical device instead of specially controlled medical device. Affected units include specific lot numbers for spinal implants.
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 spinal implant device called the END RING 12MM DIA/0 DEG (TI) because it was incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could lead to improper regulatory oversight and potential misuse of the implant.
The device was incorrectly labeled as a general medical device instead of a specially controlled medical device. This labeling error could result in the device being subject to less stringent regulatory controls than required for specialized spinal implants, potentially leading to improper use or safety issues.
Surgeons and medical facilities using the END RING 12MM DIA/0 DEG (TI) spinal implant device with specific lot numbers are affected. Patients receiving the implant may be at risk if the device is used without proper regulatory oversight.
Check for the product name 'END RING 12MM DIA/0 DEG (TI)' with product number 495.385. Affected units include lot numbers 20P5299, 20P5316, 20P5321, 35P3361, and H861583.
Look for the product number 495.385 and specific lot numbers listed in the recall notice.
The product was incorrectly labeled as a general medical device instead of a specially controlled medical device, which could lead to improper regulatory oversight.
Lot numbers 20P5299, 20P5316, 20P5321, 35P3361, and H861583 are affected.
The recall does not specify a stop-use instruction, so users should check the product label for the specific lot numbers to determine if it is affected.
We’ve drafted a message you can send Synthes to request your refund or repair — edit it as you like.
Subject: Recall Z-0409-2021 — Synthes Synthes Hello, I own a Synthes that is covered by recall Z-0409-2021 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.
