FDAClass IIJune 3, 2015

EXPEDIUM Spine System/Synapse System recall

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN…

Why was EXPEDIUM Spine System/Synapse System recalled?

Device does not mate as intended.

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: ARNDC6 & ARN DC7

Product
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN…
Recalling firm
DePuy Spine, Inc.
Quantity
183 devices
Distribution
US: PA and OUS: SE, BE, IT, PT
Recall date
June 3, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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