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Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm… recallZ-2199-2016 · Synthes (USA) Products LLC · initiated May 31, 2016

Class II Terminated All recalls posted in July 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Labeling False and Misleading

What the company is doing

DePuy Synthes mailed an URGENT MEDICAL DEVICE FIELD SAFETY NOTIFICATION letter to their customers (Hospital Personnel, including Imaging Department Personnel and DePuy Synthes Colleague) to inform them of the recall and actions to take. The letter identified the affected, problem and actions to be taken. The letter instructed customers not to use the affected Instruments which are labeled or etched MR Safe and MR Conditional during MRI scans. Customers were asked to review the information contained in the Field Safety Notification letter and complete the Verification Section located on page 3 of this notification. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant.

Recall details

Recall number
Z-2199-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 31, 2016
Posted by the FDA
Jul 12, 2016
Recalling firm
Synthes (USA) Products LLC
Quantity
19 units
Product code
HWE
FDA submissions
K043310
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.

Product description

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 MR conditional Instruments are used to assist with the insertion or removal of an implant.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

66 devices cleared under K043310 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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