Agency classClass IIOur severity:Severe FDA (Devices)·Z-2627-2014·Announced 2014-09-17

Stryker Recalls Aria Inserter Devices Due to Product Fracturing

Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.

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 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 classification is Class II, and the source cites 'complaints of product fracturing' for a surgical instrument, which constitutes a significant injury risk under the rubric for structural defects or significant injury reports.

Plain-English summary

Stryker Spine has initiated a recall of its Aria Standard and Specialty Implant Inserters. The recall involves 57 units of the Specialty Aria Inserter (REF IS3021ARI), which is a non-sterile instrument used for implant insertion into the disc space. The affected units are identified by Catalog #IS3021ARI and Lot #s 20774, 20798, 20805, and 21990.

The recall was initiated due to complaints of product fracturing. The Aria Inserter PEEK Spacer System is intended for use as an aid in spinal fixation. The devices are hollow implants offered in various lengths, heights, and lordotic angles, featuring serrations for multidirectional fixation.

The affected units were distributed worldwide, including in the United States (specifically OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, AL, CO, and WI) and internationally to Australia. Healthcare providers and facilities should stop using the affected devices and contact Stryker Spine for further instructions.

The recalled product

Product: Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in…
Manufacturer: Stryker Spine
Category: Medical Device — Surgical Instrument
Hazard: product-fracturing
Affected units: 57

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 (4)

Catalog #IS3021ARI
Lot #'s 20774
20798
20805 and 21990

Distribution

Distributed in 24 states:

Part of a larger recall action

This product is one of 2 recalled by Stryker Spine 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 →

Same manufacturer · Stryker Spine

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