LCP 223.591Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982157973), received between Aug 31, 2018 and Jan 13, 2026 — classified as 4 injuries.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE HARDWARE REMOVAL AS SCREWS LOOSENED FROM PLATE CONSTRUCT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 24060414 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SURGEON REMOVED A PLATE FROM A PREVIOUS SURGERY AND IT LOOKED TO HAVE A DISCOLORATION IN THE SCREW HOLES. THIS WAS A REVISION SURGERY FOR A HARDWARE REMOVAL NONUNION OF AN ULNA FOLLOWED BY ANOTHER ORIF. ORIGINAL SURGERY WAS DONE (B)(6) 2024 FOR AND OPEN ULNA ORIF. REVISION SURGERY DONE (B)(6) 2024. THE SURGERY WAS COMPLETED WITH NO FRAGMENTS GENERATED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 20446610 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED PRODUCT COMPLAINT : (B)(4).

  Patient problems: No Code Available

  MAUDE report 9278950 ↗
• InjuryAug 31, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2011 PATIENT UNDERWENT REVISION SURGERY OF RIGHT TOTAL HIP ARTHROPLASTY WITH CUP CAGE CONSTRUCT AND PLATE WITH WELL-FIXED REASONABLY POSITIONED COMPONENTS. POST-OPERATIVE ON (B)(6) 2013, PATIENT HAD AN X-RAY DUE TO PAIN THAT REVEALED A BROKEN POSTERIOR COLUMN PLATE AND A BROKEN ISCHIAL FLANGE ON THE CAGE. PATIENT ALSO HAD A NON-UNION WITH DEGENERATIVE CHANGES IN THE SACROILIAC JOINT WAS WELL AS LUMBER SPINE. IT IS UNKNOWN IF THE PATIENT HAD A REVISION SURGERY. THE SURGEON'S DECIDED TO MONITOR FOR MIGRATION. CONCOMITANT DEVICES REPORTED: LOCKING SELF TAPPING SCREW 212.104 QUANTITY 1, LOCKING SELF TAPPING SCREW 212.110 QUANTITY 1, LOCKING SELF TAPPING SCREW 212.112 QUANTITY 2, LOCKING SELF TAPPING SCREW 212.113 QUANTITY 3, LOCKING SELF TAPPING SCREW 212.213 QUANTITY 1. (B)(4) CAPTURES DEPUY JOINT RECON DEVICES. THIS REPORT IS FOR ONE (1) 3.5 MM LCP PLATE 9 HOLES 124 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 7837670 ↗

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,