FDAClass IIJune 12, 2013

Straight Impactor - Dorado IBC recall

Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during…

Why was Straight Impactor - Dorado IBC recalled?

During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

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: 20856

Product
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during…
Recalling firm
SpineFrontier, Inc.
Quantity
10
Distribution
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Recall date
June 12, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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