NA 47-4828-018-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024100688), received between Mar 27, 2020 and Mar 27, 2020 — classified as 1 injury.

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

4 other recalls cover devices cleared under the same FDA submission (K063303); 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.

• InjuryMar 27, 2020Corroded; Corroded

  IT WAS REPORTED THAT A PLATE WAS EXPLANTED DUE TO THE CUSTOMER THINKING THAT IT WAS LINKED TO AN ONGOING INVESTIGATION OF THE PLP PRODUCT AT THE HOSPITAL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Code Available

  MAUDE report 9888002 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063303. One submission often covers many models, so check the product and lot details in each record.

• Z-0312-2020 · Oct 10, 2019 · Terminated
  Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 4749
• Z-1674-2016 · May 4, 2016 · Terminated
  Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
• Z-1103-2016 · Jan 11, 2016 · Terminated
  Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7M
• Z-1042-2014 · Oct 11, 2013 · Terminated
  1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUC