FDAClass IIAugust 29, 2018

Dymaxeon 5.5 Curved Rod recall

Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide…

Why was Dymaxeon 5.5 Curved Rod recalled?

Packages labeled as containing 110mm rods may contain 100mm rods.

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 779C4

Product
Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide…
Recalling firm
Back 2 Basics Direct LLC
Quantity
10
Distribution
The products were distributed to the following US states: OH.
Recall date
August 29, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls