Acumed LLC recalls 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varyi…

Recall date

January 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1199-2017

FDA classification

Class II

Brand / firm

Acumed LLC

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.