Cancellous Screw, Locking SH 37352-38-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120047295373), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K051642); 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.

• MalfunctionJul 17, 2024Inaccurate Information; Inaccurate Information

  DURING THE QUALITY INSPECTION OF A RETURNED LOANER SET FROM AUSTRIA, WE HAVE DETECTED, THAT A CLASS II TITANIUM IMPLANT BONE SCREW HAS THE WRONG ARTICLE NUMBER AND LOT NUMBER LASER MARKED ON IT. THE LABEL STATES THAT IT IS THE ARTICLE NUMBER 37352-38-N WITH LOT NO. 679/022244, WHICH COMPLIES WITH THE ARTICLE ITSELF, BUT THE LASER MARKING SHOWS THE ARTICLE NUMBER 37352-36-N WITH LOT NO. 679/022241. THE DISCREPANCY IN LASER MARKING OF THIS BONE SCREW COULD BE LIMITED TO ONE SINGLE BATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760912 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051642. One submission often covers many models, so check the product and lot details in each record.

• Z-1595-2026 · Jan 23, 2026 · Open, Classified
  FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article Number: 21064-60.