The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2199-2016·Announced 2016-07-20

Synthes 1.1mm Drill Bit Recalled for Incorrect MR Safety Labeling

Synthes (USA) Products LLC is recalling 19 units of 1.1mm Drill Bits because their MR safety labeling does not meet current ASTM standards.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding MR safety standards. No injuries or illnesses are reported, and the hazard is related to documentation and labeling compliance rather than a direct physical defect causing immediate harm.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 19 units of Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm. The affected devices are identified by lot # 4326989 and were manufactured on 9/28/2001. These instruments are used to assist with the insertion or removal of implants.

The recall was initiated because the affected devices were distributed, etched, and/or labeled with MR Safety information that does not meet the current ASTM standard. The devices were distributed nationwide in the states of AR, CA, CO, CT, DC, ID, IL, KY, LA, MA, MD, MN, MO, MS, MT, NY, PA, and TX.

Healthcare facilities and consumers should stop using the affected drill bits and contact Synthes (USA) Products LLC for further instructions.

The recalled product

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 MR conditional Instruments are used to assist with the insertion or removal of an implant.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Surgical Instruments
Hazard
Affected units
19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Part of a larger recall action

This product is one of 11 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →

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