FDAClass IIFebruary 22, 2017

6-hole Pubic Symphysis plate recall

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…

Why was 6-hole Pubic Symphysis plate 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot number: 383813

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…
Recalling firm
Acumed LLC
Quantity
15 units
Distribution
Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
Recall date
February 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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