LCP 223.661Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982158109), received between Feb 14, 2018 and Nov 16, 2018 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT WENT TO THE EMERGENCY ROOM (ER) AND REPORTED TO HAVE FALLEN THREE DAYS PRIOR WHILE ON CRUTCHES. THE PATIENT HAD PREVIOUSLY UNDERGONE OPEN REDUCTION OF THE LEFT FEMUR WITH A LOCKING COMPRESSION PLATE (LCP) PLATE, FIVE (5) LOCKING SCREWS AND THREE (3) CORTICAL SCREWS ON (B)(6) 2017. A REVISION SURGERY WAS PERFORMED. SURGICAL OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREW 5.0 X 30MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). LOCKING SCREW 5.0 X 32MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). LOCKING SCREW 5.0 X 34MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). LOCKING SCREW 5.0 X 38MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). LOCKING SCREW 5.0 X 40MM (PART: UNKNOWN. LOT: UNKNOWN, QUANTITY: 1). CORTICAL SCREW 4.5 X 30MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). CORTICAL SCREW 4.5 X 38MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). CORTICAL SCREW 4.5 X 50MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A 3.5MM LCP PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8077670 ↗
• InjuryFeb 14, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT WAS IMPLANTED WITH 4.5 / 5.0 LOCKING COMPRESSION PLATE, FIVE (5) LOCKING SCREWS AND THREE (3) CORTICAL SCREWS. POST-OPERATIVE, ON AN UNKNOWN DATE, PATIENT EXPERIENCED A BREAK OF A 4.5 / 5.0 LOCKING COMPRESSION PLATE. PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6) 2018. CONCOMITANT DEVICES REPORTED: 5.0MM X 30MM LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 5.0MM X 32MM LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 5.0MM X 34MM LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 5.0MM X 38MM LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 5.0MM X 40MM LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 4.5MM X 30MM CORTICAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 4.5MM X 38MM CORTICAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), 4.5MM X 50MM CORTICAL SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) 4.5MM BROAD LCP® PLATE 16 HOLES/296MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7270848 ↗

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,