NA 02.226.218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982058768), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (1 report).

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 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.

• MalfunctionMar 8, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE TIP OF THE SCREW MUST BE DAMAGED AS IT WILL NOT GO OVER THE GUIDE WIRE PRIOR TO SURGERY AT THE BACK TABLE. THERE WAS NO IMPACT ON PATIENT. THERE WAS NO DELAY IN STARTING THE SURGERY SINCE ANOTHER WAS READILY AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324975 ↗

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