NA 04.226.220Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982122520), received between Jul 31, 2023 and Jul 31, 2023 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K012945, K021556, K161616); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 IN WHICH THE PRODUCTS IN QUESTION WERE IMPLANTED. THE PATIENT HAS BEEN PRESENTING WITH A REACTION AT THE SITE OF THE PROCEDURE FOR OVER 1 YEAR. PRODUCTS HAVE NOT BEEN EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS FOR A 2.4MM TI HEADLESS COMPRESSION SCREW-SHORT THREAD 20MM. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17424252 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012945, K021556, K161616. One submission often covers many models, so check the product and lot details in each record.

• Z-0890-2013 · Feb 12, 2013 · Terminated
  Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antiprur