NA 212.102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982151766), received between Nov 11, 2022 and Nov 11, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K000684, K072095); 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.

• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION DUE TO RIGHT MEDIAL MALLEOLUS FRACTURE. IN RADIOLOGY (B)(6) 2021 STABLE FIXATION RIGHT SYNDESMOSIS AND RIGHT FIBULA. MEDIAL MALLEOLAR FRAGMENT WITH DISPLACEMENT. THIS REPORT IS FOR ONE 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 12. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Physical Asymmetry

  MAUDE report 15779034 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K072095. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,