Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-2199-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 31, 2016

Date Posted: July 20, 2016

Recall Number: Z-2199-2016

Event ID: 74416

Reason for Recall:

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.

Status: Terminated

Product Quantity: 19 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated