LCP 223.571Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982157935), received between Dec 28, 2017 and May 27, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684, K082807); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 7 PATIENTS THAT WERE IMPLANTED WITH DEPUY SYNTHES (DPS) LCP 2.0 DISTAL ULNA PLATE. IMPLANTATION WAS BETWEEN 2008 AND 2023 AT (B)(6). PATIENT NUMBER 2. PATIENT IS AN 80-YEAR-OLD FEMALE WHO UNDERWENT DISTAL ULNA FRACTURE FIXATION. REASON FOR IMPLANTATION WAS SUBCAPITAL FRACTURE (EXTRA-ARTICULAR). POST OP COMPLICATION INCLUDED PAIN, LEFT WRIST, PAINFUL ORTHOPEDIC HARDWARE, LEFT WRIST AND NONUNION DISTAL ULNA FRACTURE. INTERVENTION WAS REMOVAL OF ULNA HARDWARE FROM LEFT WRIST WITH DISTAL ULNA RESECTION.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 22089973 ↗
• MalfunctionNov 29, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS RUST IN TWO SPOONS, AND THE MINI FRAG BENDERS DIDN¿T BEND AS WELL WHEN USED. THE 7H LOCKING SCREW DID NOT LOCK IN THE PLATE AFTER BENDING OF THE PLATE. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 3.5MM LCP PLATE 7 HOLES 98MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226561 ↗
• InjuryAug 28, 2019Break; Break

  UPDATE: REVISION SURGERY AND HARDWARE REMOVAL OCCURRED (B)(6) 2019.

  Patient problems: No Code Available; Pain

  MAUDE report 8940129 ↗
• InjuryJan 8, 2018Break; Break

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A RIGHT MID-SHAFT HUMERUS WAS PERFORMED ON (B)(6) 2017 DUE TO A BROKEN PLATE AND NON-UNION. ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE IN (B)(6) 2017. SUBSEQUENTLY IT WAS IDENTIFIED THAT THE PLATE HAD BROKEN. THE PLATE AND ALL SCREWS WERE REMOVED - ALL SCREWS WERE INTACT. THE PLATE BROKE IN THE CENTER HOLE (7-HOLE PLATE). THE NON-UNION WAS TREATED WITH VIVIGEN. NO INFECTION WAS PRESENT. THE SURGEON STATED THAT THE PATIENT MAY HAVE BEEN NON-COMPLIANT WITH POST-OPERATIVE WEIGHT BEARING INSTRUCTIONS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICE(S) REPORTED: 3.5 MM CORTEX SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 2) , 3.5 MM LOCKING SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 4). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A PLATE.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7173156 ↗
• InjuryJan 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2017, DUE TO A NONUNION OF AN ULNA FRACTURE. ORIGINAL IMPLANT DATE WAS ON AN UNKNOWN DATE IN 2016. THE LOCKING COMPRESSION PLATE (LCP) AND SCREWS WERE REMOVED INTACT AND REPLACED WITH A RECON PLATE AND SCREWS. THE PATIENT ALSO RECEIVED AN AUTOLOGOUS MEDIAL FEMORAL EPICONDYLE VASCULARIZED BONE GRAFT. THE PHYSICIAN STATED THE NONUNION WAS RELATED TO THE PATIENT BIOLOGY. THERE WAS NO REPORT OF SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 3.5 MM LCP PLATE 7 HOLES 98 MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7172885 ↗
• InjuryDec 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO NON-UNION OF A ULNA BONE. THE ORIGINAL SURGERY DATE OCCURRED ON (B)(6) 2016 DUE TO A FOREARM FRACTURE. ALL PREVIOUSLY IMPLANTED HARDWARE WAS REMOVED INTACT AND INCLUDED A 3.5 MM LCP PLATE 7 HOLES AND 6 (3.5 MM CORTEX SCREWS). THE PATIENT WAS REVISED TO A 9 HOLE LCP PLATE WITH 8 (3.5 MM CORTEX SCREWS). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. PATIENT OUTCOME WAS NOTED AS STABLE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7151681 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684, K082807. 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,