Logical 111-12-5652Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09348215001056), received between Apr 27, 2021 and Apr 27, 2021 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K121297); 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.

• MalfunctionApr 27, 2021Inaccurate Information; Inaccurate Information

  A COMPLAINT HAS BEEN RAISED REGARDING DISCREPANCY BETWEEN PRODUCT PART NUMBER AND LABEL PART NUMBER BY THE CUSTOMER. AFTER INVESTIGATION, IT HAS BEEN FOUND THAT PARTS OF LOT 71541-1 HAS BEEN WRONGLY LABELLED.

  Patient problems: Insufficient Information

  MAUDE report 11735897 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121297. One submission often covers many models, so check the product and lot details in each record.

• Z-1694-2021 · Apr 20, 2021 · Terminated
  Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
• Z-0920-2018 · Feb 2, 2018 · Terminated
  Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads