Southern Implants recalls specific dental implants due to incorrect labeling on inner labels. This may cause confusion in surgical use. Affected units have lot code 251J00d2.
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Southern Implants is recalling a specific dental implant model (IBR12d-13) because the inner label shows an incorrect code (IBNT12d- 13) instead of the correct one. This labeling error could lead to confusion during surgical procedures, potentially affecting patient safety.
The inner label on the implant incorrectly shows the code 'IBNT12d-13' instead of the correct 'IBR12d-13'. This labeling error could cause confusion during surgical procedures, potentially leading to incorrect implant use.
Dental surgeons and patients who have received the specific implant model with lot code 251J00d2 are affected. Patients using this implant for dental prosthetics are at risk of confusion during surgical procedures.
Check for the implant model labeled 'SOUTHERN IMPLANTS REF IBR12d-13' with lot code 251J00d2. The inner label should read 'IBR12d-13' correctly; if it shows 'IBNT12d-13', it is affected.
Verify the inner label reads 'IBR12d-13' instead of 'IBNT12d-13'.
The inner label incorrectly shows 'IBNT12d-13' instead of the correct 'IBR12d-13', which could cause confusion during surgical procedures.
Check the inner label for the correct code 'IBR12d-13'. If it shows 'IBNT12d-13', contact Southern Implants for guidance.
The official recall does not mention a fix; affected units should be checked for correct labeling.
We’ve drafted a message you can send Southern Implants to request your refund or repair — edit it as you like.
Subject: Recall Z-1386-2018 — Southern Implants Southern Implants Hello, I own a Southern Implants that is covered by recall Z-1386-2018 from Southern Implants. 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.
