Class II — Potential Health Hazard

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

6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates Recalled by Acumed LLC Due to The 6-hole Pubic Symphysis plate (PN 70-0451) is...

Date: January 19, 2017
Company: Acumed 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 Acumed LLC directly.

Affected Products

6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

Quantity: 15 units

Why Was This Recalled?

The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135  Ti alloy) and was distributed.

Where Was This Sold?

Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain

About Acumed LLC

Acumed LLC has 14 total recalls tracked by RecallDetector.

Related Recalls

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