Acumed LLC: Medical Device Recall in 2017 - (Recall #: Z-1199-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 19, 2017

Date Posted: February 22, 2017

Recall Number: Z-1199-2017

Event ID: 76332

Reason for Recall:

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.

Status: Terminated

Product Quantity: 15 units

Code Information:

Lot number: 383813

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated