VA-LCP 02.111.631KSRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982261571), received between Mar 23, 2020 and Mar 23, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K012114, K071184, 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING DISTAL RADIUS OPEN REDUCTION INTERNAL FIXATION (ORIF), THE NURSE PRESENTED THE SURGEON WITH AN EXPIRED STERILE BOXED IMPLANT. THE IMPLANT WAS PLACED INSIDE THE PATIENT FOR POSITIONING BUT WAS NOT FIXED WITH SCREWS. THE IMPLANT WAS REMOVED FROM THE STERILE FIELD ONCE THE PAST EXPIRATION WAS REALIZED. THE DEVICES WERE REMOVED EASILY. MEDICAL INTERVENTION IS DONE WITH PROPHYLACTIC ANTIBIOTICS ADMINISTERED AND ANTIBIOTIC WASH OUT. THE PATIENT HAD JUST UNDERGONE A BI-POLAR HIP PROCEDURE IMMEDIATELY PRECEDING THE DISTAL RADIUS ORIF, IN WHICH THE EXPIRED IMPLANT WAS INTRODUCED TO THE FIELD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIXTY (60) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.4MM VA LCP 2-COL DSTL RAD PL 6HH/3HS/LT KIT-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 9865224 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012114, K071184, K083694. 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-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
• Z-0489-2007 · Dec 5, 2006 · Terminated
  LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465