VA-LCP 04.111.621Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982101808), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT A DISTAL RADIUS PLATE WAS REMOVED ON (B)(6) 2019. ACCORDING TO THE SURGEON, THE PLATE WAS PLACED TOO DISTALLY WHICH CAUSED A TENDON TO RUPTURE OVER TIME. TWO (2) OF THE 2.4 VARIABLE ANGLE (VA) LOCKING SCREW BROKE DURING REMOVAL, BUT FRAGMENTS WERE REMOVED SUCCESSFULLY. A TENDON REPAIR WAS THEN PERFORMED. THE ORIGINAL SURGERY WAS DONE IN RICHARDSON, TEXAS ABOUT FIVE (5) YEARS AGO. THE PLATE AND SCREWS WERE SUCCESSFULLY REMOVED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES: LOCKING SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 4), CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 2). THIS REPORT IS FOR A TITANIUM (TI) VARIABLE-ANGLE LOCKING COMPRESSION PLATE (VA-LCP). THIS IS REPORT 1 OF 1 FOR (B)(4) AND CAPTURES THE POSTOPERATIVE TENDON RUPTURE. THE BREAKAGE OF SCREWS DURING REMOVAL IS CAPTURED UNDER RELATED (B)(4).

  Patient problems: Rupture

  MAUDE report 8469484 ↗

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