FDAClass IIJune 11, 2014

Synthes XRL Medium Trial - Central Body recall

Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal…

Why was Synthes XRL Medium Trial - Central Body recalled?

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

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?

Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.

Product
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal…
Recalling firm
Synthes, Inc.
Quantity
3
Distribution
US Distribution including the states of FL, NJ and MN.
Recall date
June 11, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls