McKesson SJ497GXRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10612479214627), received between Oct 12, 2021 and Oct 12, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K963253); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2021Break; Unraveled Material; Break; Unraveled Material

  ACCORDING TO THE REPORTER, 7 DAYS POSTOPERATIVE TO EXCISION (DEEP LAYER CLOSURE), THE SUTURE BROKE SO WOUND REOPENED. THE PATIENT HAD TO COME BACK THE NEXT DAY FOR EXCISION AND PATIENT WAS RE-SUTURED USING A COMPETITOR BRAND.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12619484 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253. One submission often covers many models, so check the product and lot details in each record.

• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI