The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1806-2013·Announced 2013-07-31

Aesculap ProSpace PEEK Spinal Implant Recalled for Incorrect Etching

Aesculap is recalling nine ProSpace PEEK spinal implants because they are incorrectly etched with an 8-degree lordosis instead of the labeled 5-degree lordosis.

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 2/5 (Moderate).

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 classified as FDA Class II, which corresponds to a moderate severity score. The issue is a manufacturing defect (incorrect etching) where the label is correct, and no injuries or illnesses are reported in the source text.

Plain-English summary

Aesculap Implant Systems, LLC has initiated a recall of the Aesculap ProSpace PEEK 5 degree Implant (8 x 8.5 x 22 mm, Part no. SN038P). The recall involves nine units of the device, which is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine.

The recall was initiated because the devices are incorrectly etched with an 8-degree lordosis instead of the specified 5-degree lordosis. The source text notes that the devices are labeled correctly, but the physical etching on the implant may be incorrect.

The affected units were distributed in the United States, including the states of Nevada and Michigan. The source text does not provide specific instructions for consumers or healthcare providers regarding the next steps for these implanted devices.

The recalled product

Product
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar…
Manufacturer
Aesculap, Inc.
Category
Medical Device — Spinal Implant
Hazard
Affected units
9

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 (2)

  • Part no. SN038P
  • batch number 51915765

Distribution

Distributed in 2 states:

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