Novafil SPB-1213GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521100763), received between Jun 27, 2019 and Aug 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K990952); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Dec 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1175-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Break; Break

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC TEMPOROMANDIBULAR JOINT ARTHROPLASTY, WHILE CLOSING OF THE FACIAL SKIN, THE THREAD BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283092 ↗
• MalfunctionJun 27, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLES KEPT ON BREAKING AND FELL OFF THE SUTURES.

  Patient problems: No Information

  MAUDE report 8740222 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990952. One submission often covers many models, so check the product and lot details in each record.

• Z-1181-2023 · Dec 2, 2022 · Open, Classified
  Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 8