Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation

Plain-English summary

Zimmer, Inc. is recalling the Zimmer Spine Ardis Inserter, a prescription, non-sterile medical device. The recall involves 315 units, with 172 distributed in the United States and the remainder distributed worldwide in Australia, El Salvador, France, and Singapore.

The recall was initiated after Zimmer Spine received reports that the PEEK Ardis Interbody Spacer can break into fragments if too much lateral force is applied to the Ardis Inserter. If the spacer breaks during implantation, it can cause surgical delays of up to 60 minutes. Additionally, the sharp edges of the broken implant may contact and damage adjacent structures, potentially requiring further surgical intervention.

Healthcare providers and patients should contact Zimmer, Inc. for instructions on how to handle the recalled devices. The source text does not specify a specific action for consumers, but the device is a prescription item used in surgical settings.

The recalled product

Product

Zimmer Spine Ardis Inserter, Rx, non-sterile

Manufacturer

Zimmer, Inc.

Category

Medical Device — Orthopedic Implant

Hazard

• structural-failure
• sharp-edges
• surgical-complication

Is your product affected?

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

Distribution

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