LCP 249.674Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982171214), received between Mar 12, 2018 and Jan 29, 2021 — classified as 3 injuries.

4 other recalls cover devices cleared under the same FDA submission (K063049); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT RADIAL HEAD REVISION RECONSTRUCTION, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT AND WAS IMPLANTED WITH A NON-SYNTHES DEVICE DUE TO A RIGHT ELBOW RADIAL HEAD REPLACEMENT FAILURE, SYMPTOMATIC HARDWARE WITH STIFFNESS AND INCREASING PAIN. ON (B)(6) 2015, THE PATIENT HAS PRESENTED DISCOMFORT WITH PAIN OVER THE RIGHT ELBOW WHICH RADIATES TO THE RIGHT ELBOW. THE PATIENT FELL DOWN ON HER ELBOW AND SUSTAINED A FRACTURE DISLOCATION. SHE ALSO HAD NERVE SYMPTOMS MOSTLY IN THE ULNAR DISTRIBUTION. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT OLECRANON OPEN REDUCTION INTERNAL FIXATION, RADIAL HEAD RESECTION WITH RADIAL HEAD REPLACEMENT AND OPEN REDUCTION OF RADIAL HEAD AND WAS IMPLANTED WITH DEPUY SYNTHES 20MM DIAMETER HEAD AND A 4 HOLE LONG RIGHT OLECRANON PLATE. THE PATIENT WAS DIAGNOSED WITH RIGHT ELBOW FRACTURE-DISLOCATION, RADIAL HEAD OLECRANON COMMINUTED FRACTURE AND ULNAR NEURAPRAXIA. ON (B)(6) 2016, CT RIGHT UPPER EXTREMITY SHOWS PLATE AND SCREW FIXATION OF THE PROXIMAL ULNA. COMMINUTED INTRA-ARTICULAR FRACTURE NOW WITH BRIDGING CALLUS FORMATION. BRIDGING CALLUS FORM

  Patient problems: Bone Fracture(s); Muscular Rigidity; Pain

  MAUDE report 11252454 ↗
• InjuryOct 11, 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 HARDWARE REMOVAL DUE TO THE BONE BEING HEALED AND TO AVOID INFECTION. SCREWS REMOVED WERE FIVE (5) UNKNOWN 3.5 VARIABLE ANGLE (VA) LOCKING SCREWS, SIX (6) UNKNOWN 3.5 CORTEX SCREWS, FOUR (4) UNKNOWN 2. 4 CORTEX SCREWS, 1 (ONE) 3.5 VA-LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE AND ONE (1) 2.4 LCP PLATE 4 HOLES. ALL HARDWARE SUCCESSFULLY REMOVED WITH NO ISSUES. ORIGINAL IMPLANT WAS ON APRIL 30,2018. THERE WERE NO KNOWN COMORBIDITIES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (5) REPORTS TOTALING SEVENTEEN (17) DEVICES. THIS COMPLAINT IS FOR (1) 2.4 LCP PLATE 4 HOLES. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7958055 ↗
• InjuryMar 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B)(6) 2016 AFTER A PATIENT SUFFERED A GUNSHOT WOUND WHERE ONE (1) 2.4MM LOCKING COMPRESSION PLATE (LCP), FOUR (4) 7.3MM CANNULATED SCREWS, FOUR (4) WASHERS, TWO (2) 2.4MM LOCKING SCREWS, AND ONE (1) 2.4MM CORTEX SCREW WAS IMPLANTED. POST-OPERATIVELY, PATIENT RETURNED TO SURGERY DUE TO A NONUNION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018, WHERE ALL PREVIOUS IMPLANTS WERE REMOVED AND PATIENT RECEIVED A TOTAL HIP REPLACEMENT. THERE WAS NO SURGICAL DELAY AND SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS OK. THIS COMPLAINT INVOLVES 12 PARTS (FOUR UNK-7.3MM CANNULATED SCREWS, FOUR WASHERS, ONE PLATE, TWO UNK-2.4M LOCKING SCREWS AND ONE UNK-2.4MM CORTEX SCREW). THIS REPORT IS FOR (1) PLATE THIS REPORT IS 3 OF 8 FOR (B)(4)

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7332528 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen