LCP 249.684Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982171290), received between Mar 29, 2019 and Jun 18, 2021 — classified as 2 injuries, 1 malfunction.

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

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.

• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL SURGERY OF 2.7MM LCP L-PLATES, OBLIQUE LEFT, 2 HOLES AND UNKNOWN SCREWS DUE TO NON-UNION ON (B)(6) 2021. THERE WAS BONE LOSS AT THE FRACTURE SIDE. THE INITIAL OPERATION WAS A GROSSLY OPEN FIREWORK INJURY WITH FRACTURES TO THE DISTAL RADIUS ON (B)(6) 2020. A NEW 2.7 CONDYLAR PLATE WAS PLACED, AND ILIAC CREST BONE GRAFT WAS HARVESTED AND UTILIZED. PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS REPORT IS FOR (1) 2.7MM LCP(TM) CONDYLAR PLATE. THIS REPORT IS 1 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12028419 ↗
• MalfunctionJan 28, 2020Break; Break

  LIBERTAS: IT WAS REPORTED THAT ON (B)(6) 2019, A LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE WAS NOTED TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF THE RETURNED DEVICES AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.7MM LCP(TM) CONDYLAR PLATE 7 HOLES SHAFT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9639728 ↗
• InjuryMar 29, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A REMOVAL OF HARDWARE TO BROKEN (1) LOCKING COMPRESSION PLATE (LCP) CONDYLAR PLATE, THIRTEEN (13) LOCKING SCREWS (7 LOCKING SCREWS BROKE), ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE AND 8 CORTEX SCREWS DUE TO NONUNION AND DELAYED HEALING. ALL HARDWARE REMOVED EXCEPT FOR A SHORT SEGMENT OF A 2.7 VA LOCKING SCREW SHAFT. THE PATIENT REQUIRED FUSION OF ANKLE AND UNDERWENT AN INSERTION HINDFOOT NAIL. PATIENT ORIGINALLY HAD AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF DISTAL TIBIA FRACTURE ON (B)(6) 2018. FRAGMENTS WERE GENERATED AND WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS STABLE. CONCOMITANT DEVICES REPORTED: VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE (PART # 02.118.406, LOT # UNKNOWN, QUANTITY 1); VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE (PART # 02.118.202, LOT # UNKNOWN, QUANTITY 1); UNKNOWN LOCKING SCREW

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

  MAUDE report 8466884 ↗

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