Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1199-2017 — 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

U.S. FDA — Device Enforcement · United States · 2017-01-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1199-2017
Date of alert: 2017-01-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Acumed LLC
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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