FDAClass IIJuly 20, 2016

Part # 313.250 recall

Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and…

Why was Part # 313.250 recalled?

DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.

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?

Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001

Product
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and…
Recalling firm
Synthes (USA) Products LLC
Quantity
19 units
Distribution
US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.
Recall date
July 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls