The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2197-2016·Announced 2016-07-20

Synthes Recalls 2.0mm Stardrive Screwdrivers for MR Safety Labeling Errors

Synthes (USA) Products LLC is recalling 79 units of 2.0mm Stardrive Screwdrivers 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 information. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries are rated as Moderate.

Plain-English summary

Synthes (USA) Products LLC is voluntarily recalling 79 units of Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC. The affected lots are #4341036, #4363819, and #4427699, which were manufactured between March 4, 2002, and June 6, 2002. 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 users should stop using the affected instruments and contact Synthes (USA) Products LLC for further instructions regarding the recall.

The recalled product

Product
Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an…
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Surgical Instruments
Hazard
Affected units
79

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 (6)

  • Part #313.231
  • 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC
  • lot # 4341036
  • 4363819
  • 4427699
  • mfg. 3/4/2002-6/6/2002

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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