The Recall Desk
ModerateFDA (Devices)·Z-1189-2016·Announced 2016-03-30

Zimmer Spine Universal Clamp System Recall for Updated Cleaning Instructions

Zimmer Spine is issuing a correction notice for the Universal Clamp System to provide updated cleaning and disinfecting instructions.

What this means for you

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 a voluntary precautionary correction notice to update cleaning and disinfecting instructions, which aligns with the criteria for a moderate severity score involving minor procedural updates without reported injuries.

Plain-English summary

Zimmer Biomet is initiating a Medical Device Correction Notice for the Universal Clamp System (IFU reference: SNA027-N-90001) and the Instinct Java System (IFU reference: 046WAN0000T). The Universal Clamp System is a medical device used to provide stability for solid bone fusion and help reduce spinal deformities and fractures.

The recall is being initiated to provide updated cleaning and disinfecting instructions for the use of these devices. The notice applies to all lots of the Universal Clamp System, with a total quantity of 3,484 units affected.

The devices were distributed nationwide in the United States, including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, MD, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, PA, TN, TX, WA, and WI. Healthcare providers and facilities should refer to the updated instructions provided in the correction notice for proper cleaning and disinfecting procedures.

The recalled product

Product
Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
Manufacturer
Zimmer Spine, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
3,484

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 (1)

  • All lots

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Spine, Inc. 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 2 products in this recall →

Related recalls

Same manufacturer · Zimmer Spine, Inc.

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Same hazard · infection risk

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