The Recall Desk
HighFDA (Devices)·Z-2059-2015·Announced 2015-07-22

Exactech Spine Set Screw Recalled for Incorrect Thread Form

Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect (incorrect thread form) in a spinal implant, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Exactech, Inc. is recalling 749 units of the Altiva Large Set Screw, Catalog Number 28202, Lot Number AS05107. These medical devices are intended to provide immobilization and stabilization of spinal segments.

The recall was initiated because the screws have an incorrect thread form. The affected devices were distributed in the states of Florida, Georgia, Illinois, New York, Texas, and Washington.

Healthcare providers and patients should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Manufacturer
Exactech, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
749

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)

  • Catalog Number 28202
  • Lot Number AS05107

Distribution

Distributed in 6 states:

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