FDAClass IIJune 28, 2017

DePuy Mitek LATARJET EXPERIENCE Top Hat Tap recall

DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent…

Why was DePuy Mitek LATARJET EXPERIENCE Top Hat Tap recalled?

Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

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?

GTN: (01)10886705026814 Lot codes: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, 17C03

Product
DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent…
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
153 units
Distribution
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Recall date
June 28, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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