NA 72203856Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885554030129), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K122059); 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.

• MalfunctionFeb 22, 2019Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY, THE EXPIRATION DATES ON THE BOX AND THE INNER POUCH DID NOT MATCH. THE BOX WAS LABELED AS 02/01/2019 AND THE INNER POUCH WAS LABELED AS 02/2019. THE CORRECT EXPIRATION DATE IS 02/04/2019 AND THE DEVICE WAS USED ON THE PATIENT ON (B)(6) 2019. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361941 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122059. One submission often covers many models, so check the product and lot details in each record.

• Z-2746-2020 · Jun 24, 2020 · Open, Classified
  SUTUREFIX ULTRA Suture, Product number 72203855
• Z-2045-2014 · Jun 2, 2014 · Terminated
  SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
• Z-2048-2014 · Jun 2, 2014 · Terminated
  SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
• Z-2049-2014 · Jun 2, 2014 · Terminated
  SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
• Z-2047-2014 · Jun 2, 2014 · Terminated
  SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
• Z-2046-2014 · Jun 2, 2014 · Terminated
  SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 Fastener, fixation, nondegradable, soft tissue