LCP 223.581Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982157959), received between Jun 22, 2017 and Aug 9, 2022 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2022Device Slipped; Device Slipped

  IT WAS REPORTED ON (B)(6) 2022 THAT A REVISION PROCEDURE WAS PERFORMED TO REMOVE A 3.5 LCP THAT WAS INFECTED. THE PLATE WAS IMPLANTED AT ANOTHER FACILITY ON (B)(6) 2022. ALL HARDWARE WAS INTACT BUT LOOSE FROM THE PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5MM LCP PLATE 8 HOLES 111MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15190136 ↗
• InjuryMar 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL FOR NONUNION OF THE LOCKING COMPRESSION PLATE (LCP) EIGHT HOLE WITH TWO UNKNOWN BROKEN SCREWS. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR (1) 3.5MM LCP PLATE 8 HOLES 111MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13659279 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF ONE (1) LOCKING COMPRESSION PLATE (LCP) WITH FIVE (5) CORTEX SCREWS AND ONE (1) LOCKING SCREW DUE TO NONUNION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 8 HOLES 111MM. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12779480 ↗
• InjuryOct 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH PLATES AND SCREWS. ON (B)(6) 2021 THE HARDWARE WAS REMOVED DUE ANKLE PAIN. THIS REPORT IS FOR (1) 3.5MM LCP PLATE 8 HOLES 111MM. THIS IS REPORT 1 OF 14 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12623941 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE LOCKING COMPRESSION PLATE (LCP) SYSTEM DUE TO NONUNION OF THE RADIUS. THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN LCP SYSTEM ON (B)(6) 2019. THE PATIENT OUTCOME WAS REPORTED AS GOOD AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: 3.5MM LCP PLATE 8 HOLES 111MM (PART NUMBER 223.581, LOT H745081, QUANTITY 1), SCREWS: CORTEX (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 7), SCREWS: LOCKING (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 2). THIS REPORT INVOLVES ONE (1) LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4) IS RELATED TO (B)(4).

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 10142750 ↗
• InjuryNov 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT REMOVAL OF A 3.5MM LOCKING COMPRESSION PLATE (LCP) 8 HOLES 111MM DUE TO NONUNION FRACTURE ON THE PATIENTS ULNA. THERE WAS NO HARDWARE BROKEN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT IS FOR ONE (1) 3.5MM LCP PLATE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

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

  MAUDE report 8052396 ↗
• InjuryOct 5, 2018Break; Break

  FURTHER IT WAS REPORTED THAT A PATIENT UNDERWENT HIP SURGERY DUE TO A NON-UNION ON (B)(6) 2018 AND BOTH IMPLANTS WERE REMOVED.

  Patient problems: Bone Fracture(s); Impaired Healing

  MAUDE report 7939124 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS IMPLANTED WITH A 10MM CANNULATED TIBIAL NAIL, 5.0MM LOCKING SCREW, 3.5MM LOCKING COMPRESSION PLATE (LCP) FIBULA PLATE, AND SIX (6) UNKNOWN 3.5MM CORTEX SCREWS ON (B)(6) 2018. ON UNKNOWN DATE PATIENT DEVELOPED SKIN BREAKDOWN AND INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE ALL HARDWARE WAS REMOVED. AN ANTIBIOTIC ROD WAS PLACED UNTIL PATIENT INFECTION IS CLEARED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 7687625 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT ORIGINAL SURGERY FOR TREATMENT OF A PROXIMAL TIBIAL FRACTURE ON (B)(6) 2016. POST-OPERATIVELY, PATIENT COMPLAINED THAT WHEN THE WEATHER CHANGES,HER FEET WOULD FEEL VERY COLD ABOUT THE IMPLANT SITE. ON (B)(6) 2018, PATIENT UNDERWENT HARDWARE REMOVAL SURGERY AND THE FOLLOWING DEVICES FOURTEEN (14) WERE REMOVED - ONE (1) PROXIMAL TIBIA PLATE, ONE (1) LOCKING COMPRESSION TUBULAR PLATE, ONE (1) 8 HOLES LOCKING COMPRESSION PLATE, TWO (2) 4.5 MM CORTEX SCREWS, FOUR (4) 5.0 MM LOCKING SCREWS AND FIVE (5) 3.5 MM CORTEX SCREWS .THERE WAS NO REPORTED MALFUNCTIONS ASSOCIATED WITH ANY OF THE DEVICES. ALL OF THE DEVICES WERE REMOVED EASILY AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THE HARDWARE REMOVAL SURGERY WAS COMPLETED WITHOUT ANY REPORTED DELAY. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7313946 ↗
• InjuryDec 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MIDSHAFT HUMERAL FRACTURE FIXATION HAD FAILED AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2017. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017. THERE WAS FAILURE OF FRACTURE REDUCTION. A TOTAL OF NINE (9) IMPLANTED DEVICES WHICH INCLUDE EIGHT (8) CORTEX SCREWS AND ONE (1) PLATE WAS REMOVED. ALL IMPLANTS WERE INTACT AND DID NOT HAVE ANY ISSUES. THE PATIENT WAS REVISED TO TWO (2) PLATES AND ELEVEN (11) SCREWS WHICH WERE A COMBINATION OF CORTICAL AND LOCKING SCREWS. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY DELAY AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 8 HOLES 111MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 7138451 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY DUE TO UNHEALED FRACTURE. A SMALL PLATE AND SIX UNKNOWN SCREWS IMPLANTED ON AN UNKNOWN DATE WERE REMOVED FROM THE ULNA AND IT WAS REPLACED WITH A LONGER PLATE. ALL THE REMOVED PARTS WERE INTACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO SURGICAL DELAY. PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE 8 HOLES 111MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

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

  MAUDE report 7122394 ↗
• InjuryJun 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT ON (B)(6) 2016. INITIAL TREATMENTS INCLUDED MULTIPLE EXTERNAL FIXATION (EX-FIX) AT MULTIPLE ANATOMIC SITES, AS WELL AS TRAUMATIC AMPUTATION OF THE LOWER LEFT LEG. DURING THE FOLLOWING WEEKS PATIENT WAS RETURNED FOR SEVERAL SURGERIES WITH MULTIPLE SURGEONS TO TREAT FRACTURES OF THE LEFT FEMUR, RIGHT TIBIA, FOREARM, HAND, AND BI-LATERAL HUMERI. THE RIGHT HUMERUS WAS ORIGINALLY TREATED ON (B)(6) 2016 AND WAS LATER REVISED ON (B)(6) 2016 DUE TO NON-UNION. THIS REVISION IS ADDRESSED IN (B)(4). PATIENT WAS AGAIN RETURNED TO SURGERY ON (B)(6) 2017 DUE TO HYPER-TROPHIC NON-UNION OF THE SAME RIGHT HUMERUS FRACTURE. DURING REVISION PROCEDURE, SURGEON REMOVED ONE (1) 3.5MM LOCKING COMPRESSION PLATE (LCP) PLATE, ONE (1) 4.5MM NARROW LCP PLATE, FOUR (4) SMALL FRAGMENT SCREWS, AND FOUR (4) LARGE FRAGMENT SCREWS. ALL HARDWARE WAS REMOVED INTACT. PATIENT WAS REVISED TO A TEMPORARY DEVICE AND AN ANTIBIOTIC CEMENT SPACER TO INITIATE THE MASQUELET TECHNIQUE. THE PRESENCE OF INFECTION HAS NOT BEEN DETERMINED OR RULED OUT. PATIENT WILL REQUIRE AT LEAST ONE ADDITIONAL SURGERY FOR THIS FRACTURE. BONE GRAFTING AND DEFINITIVE FRACTURE FIXATIO

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 6660062 ↗

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,