Agency classClass IOur severity:Severe FDA (Devices)·Z-0594-2013·Announced 2013-01-02

Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation

Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up…"

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.

Lot numbers (20)

Ardis Inserter
Part number: 3256-01
Lot: 52ZW
50CL
53BB
55AB
58GS
58GT
60JY
60JZ
62KP
63HJ
64EY
68AX
71JE
75LE Part
07.00780.701
lot 76CN
part 07.00780.702
lot 76CP

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Same manufacturer · Zimmer, Inc.

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