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Recall Observatory FDA recall evidence

Device product

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.

Z-1199-2017

January 19, 2017

Class II

Product summary

Firm
Acumed LLC
Event
Event 76332
Status
Terminated
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-1199-2017

Official wording

Reason: 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.

Code information: Lot number: 383813

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.