The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2196-2016·Announced 2016-07-20

Synthes Recalls 1.5mm Stardrive Screwdrivers for Incorrect MR Safety Labeling

Synthes (USA) Products LLC is recalling 383 units of 1.5mm Stardrive Screwdrivers because their MR Safety information 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 compliance with safety standards rather than an immediate physical defect causing harm.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 383 units of Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC. The affected devices were manufactured between February 12, 2002, and May 23, 2005, and are identified by specific lot numbers including 4341033, 4589566, and 4703774.

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. These instruments are used to assist with the insertion or removal of implants.

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 should stop using the affected devices and contact Synthes (USA) Products LLC for further instructions.

The recalled product

Product
Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments…
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Surgical Instruments
Hazard
Affected units
383

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 (16)

  • Part #313.221
  • 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC
  • lot # 4341033
  • 4589566
  • 4703774
  • 4363781
  • 4589567
  • 4793575
  • 4904305
  • 4427700
  • 4589568
  • 4830581
  • 4532370
  • 4673943
  • 4871657
  • mfg. 2/12/2002-5/23/2005

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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