Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Recalled by Synthes (USA) Products LLC Due to The 2.7MM/3.5MM VA-LCP Humerus Plates were found to...

Date: September 28, 2015
Company: Synthes (USA) Products LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Synthes (USA) Products LLC directly.

Affected Products

Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, " Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus. " Olecranon and proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.

Quantity: 36

Why Was This Recalled?

The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S

Where Was This Sold?

This product was distributed to 19 states: AL, AZ, CA, FL, GA, IL, IN, KY, LA, MI, MN, NJ, NC, ND, OH, PA, TN, VA, WV

Affected (19 states)Not affected

About Synthes (USA) Products LLC

Synthes (USA) Products LLC has 162 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report