The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2626-2014·Announced 2014-09-17

Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints

Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.

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 recall is classified as FDA Class II and involves a structural defect (fracturing) in a medical device used for spinal surgery, which aligns with the rubric criteria for Severe severity involving structural defects or significant injury risks.

Plain-English summary

Stryker Spine has initiated a recall of its Aria Standard and Specialty Implant Inserters, reference number 48758500. The recall involves 64 units distributed worldwide, including in the United States and Australia. The specific lot numbers affected are 107400, 10G906, and 110214.

The recall was initiated due to complaints regarding product fracturing. These instruments are part of the Aria product brand and are used for implant insertion into the disc space as an aid in spinal fixation. The devices are interbody fusion devices intended to adapt to different patient anatomies.

Healthcare providers and facilities that have received these devices should stop using them immediately. Stryker Spine is the recalling firm responsible for managing the recall process.

The recalled product

Product
Stryker Aria Implant Inserter, REF 48758500, 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 spinal…
Manufacturer
Stryker Spine
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
64

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 (3)

  • Catalog #48758500
  • Lot #'s 107400
  • 10G906 and 110214

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 →

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