NUROLON C553DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031023888), received between Oct 9, 2025 and Oct 9, 2025 — classified as 2 malfunctions.

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

9 other recalls cover devices cleared under the same FDA submission (K946173); 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.

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.

• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN AWAKE TUMOR RESECTION FOR BRAIN TUMOR, THE PRODUCT INVOLVED WAS USED TO CLOSE THE CRANIAL DURA MATER. THE NEEDLE TIP WAS BROKEN WHEN PASSING THE NEEDLE THROUGH, SO A NEW PRODUCT OF THE SAME TYPE WAS USED, AND THE CLOSURE WAS SUCCESSFUL. DUE TO CONCERNS THAT THE NEEDLE TIP MAY HAVE REMAINED INSIDE THE BODY, A CT SCAN WAS PERFORMED AFTER THE SURGERY, BUT IT WAS DETERMINED THAT THERE WAS NO REMAINING INSIDE THE BODY. AS TWO CONSECUTIVE PACKAGES OF NEEDLE BREAKAGES OCCURRED, THE PRODUCTS FROM THE SAME LOT HAVE BEEN ISOLATED NOT TO BE USED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THE LOCATION WHERE THE NEEDLE FRAGMENT FELL IS UNKNOWN. IT WAS DETERMINED THAT THERE WAS NO REMAINING, SO ADDITIONAL TREATMENT WAS NOT REQUIRED. THE NEEDLE FRAGMENT (THE TIP) HAVE NOT BEEN RETRIEVED. NO ADVERSE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23260258 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY A SALES REP THAT, DURING AN AWAKE TUMOR RESECTION FOR BRAIN TUMOR, THE PRODUCT INVOLVED WAS USED TO CLOSE THE CRANIAL DURA MATER. THE NEEDLE TIP WAS BROKEN WHEN PASSING THE NEEDLE THROUGH, SO A NEW PRODUCT OF THE SAME TYPE WAS USED, AND THE CLOSURE WAS SUCCESSFUL. DUE TO CONCERNS THAT THE NEEDLE TIP MAY HAVE REMAINED INSIDE THE BODY, A CT SCAN WAS PERFORMED AFTER THE SURGERY, BUT IT WAS DETERMINED THAT THERE WAS NO REMAINING INSIDE THE BODY. AS TWO CONSECUTIVE PACKAGES OF NEEDLE BREAKAGES OCCURRED, THE PRODUCTS FROM THE SAME LOT HAVE BEEN ISOLATED NOT TO BE USED. IT WAS A CONTROL RELEASE NEEDLE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED FROM THE HP. THE LOCATION WHERE THE NEEDLE FRAGMENT FELL IS UNKNOWN. IT WAS DETERMINED THAT THERE WAS NO REMAINING, SO ADDITIONAL TREATMENT WAS NOT REQUIRED. THE NEEDLE FRAGMENT (THE TIP) HAVE NOT BEEN RETRIEVED. NO ADVERSE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23260255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K946173. One submission often covers many models, so check the product and lot details in each record.

• Z-0153-2027 · Sep 8, 2026 · Open, Classified
  PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
• Z-1516-2025 · Mar 7, 2025 · Open, Classified
  ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
• Z-1097-2025 · Dec 20, 2024 · Open, Classified
  PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovas
• Z-2486-2020 · Jun 10, 2020 · Open, Classified
  PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870
• Z-1841-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL Polyester Suture-ETHIBOND Green 75cm USP1 Single Armed CT-1 Product Code: X425H Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue
• Z-1842-2019 · Apr 19, 2019 · Terminated
  ETHIBOND EXCEL ETHIBOND Polvester Suture-Green 75cm USP1 Single Armed CTX Product Code: X865W Product Usage: ETHIBOND EXCEL Suture is intended for use in general soft tissue
• Z-0747-2019 · Dec 18, 2018 · Terminated
  PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approx
• Z-1839-2015 · May 8, 2015 · Terminated
  Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast ab
• Z-0492-2015 · Oct 17, 2014 · Terminated
  Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.