VA-LCP 02.111.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982031976), received between Feb 22, 2018 and Nov 2, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K083694); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2022Adverse 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 EXPERIENCED A NICKEL ALLERGY AFTER DEVICE IMPLANTATION AT THE LEFT WRIST. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/2H SHAFT/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15713477 ↗
• InjuryMar 13, 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 A REVISION CASE FOR A SUSTAINED FRACTURE PROXIMAL TO A 2-HOLE 2.4 VARIABLE ANGLE (VA) DISTAL RADIUS PLATE. THE PLATES AND SCREWS WERE REMOVED SUCCESSFULLY AND A LONGER PLATE AND SCREW WERE INSERTED TO FIX FRACTURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS 1 OF 7 FOR REPORT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9830082 ↗
• InjuryJun 27, 2019Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON REMOVED A VARIABLE ANGLE (VA) LOCKING DISTAL RADIUS PLATE FROM A PATIENT WITH A FRACTURE THAT WAS NOT HEALING. THE PLATE WAS MALPOSITIONED; THE SURGEON STATED THAT HE DID NOT PUT THE PLATE DISTAL ENOUGH. THE SURGEON STATED THAT PLATE AND SCREW CONSTRUCT HE USED WAS NOT APPROPRIATE FOR THIS FRACTURE SINCE IT WAS SO DISTAL. A NON-SYNTHES PLATE WAS USED AFTER THE REMOVAL. THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2019. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT CONSEQUENCE WAS UNKNOWN. THIS REPORT IS FOR A VARIABLE ANGLE (VA) LOCKING DISTAL RADIUS PLATE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 8740578 ↗
• MalfunctionJun 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A DISTAL RADIUS FRACTURE PROCEDURE ON (B)(6) 2018, THE LOCKING SCREW DID NOT THREAD INTO THE VARIABLE ANGLE (VA) LOCKING COMPRESSION (LCP) DISTAL RADIUS PLATE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT LOCKING SCREW. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR A 2.4MM VA-LCP 2-CLMN VLR DSTL RADIUS PL 6H HD/2H SHAFT/LEFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647390 ↗
• InjuryFeb 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2018 FOR AN OPEN REDUCTION AND INTERNAL FIXATION OF THE DISTAL RADIUS. THE HARDWARE REMOVAL WAS DUE TO TWO (2) 2.7 MM PROXIMAL CORTICAL SCREWS BACKING OUT OF THE BONE. DURING THE SURGERY THERE WAS A LOT OF FLUID IN THE WOUND INDICATING A POSSIBLE INFECTION. FIVE CULTURES WERE TAKEN TO SEE IF AN INFECTION IS PRESENT BUT RESULTS ARE NOT YET AVAILABLE. THE HARDWARE THAT WAS REMOVED WAS ONE (1) 2.4 MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) 2 COLUMN VOLAR DISTAL RADIUS PLATE, FIVE (5) 1.8 MM BUTTRESS SCREWS, ONE (1) 2.4 MM CORTICAL LOCKING SCREW, AND TWO (2) 2.7 MM CORTICAL SCREWS. ALL PARTS WERE INTACT WITH NO MALFUNCTIONS. PATIENT WAS REVISED TO A DORSAL SPANNING PLATE AND SIX (6) 2.7 MM LOCKING SCREWS. THERE WERE NO SURGICAL DELAYS, X-RAYS ARE NOT AVAILABLE, SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS STABLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7290462 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083694. One submission often covers many models, so check the product and lot details in each record.

• Z-2087-2013 · Jul 30, 2013 · Terminated
  Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the dista
• Z-2057-2013 · May 31, 2013 · Terminated
  Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and