FDAClass IIJanuary 17, 2018

Mac Pin Non-Cannulated Screw recall: Labeling Error

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Why was Mac Pin Non-Cannulated Screw recalled?

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

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?

Model #85-6560-1, Lot #132117

Product
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Recalling firm
Amendia, Inc
Quantity
41 screws
Distribution
Distribution to Georgia, USA.
Recall date
January 17, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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