The Recall Desk
HighFDA (Devices)·Z-2475-2023·Announced 2023-09-06

LIF AMP Adjustable Awl Recalled for Assembly Defect Preventing Depth Control

Alphatec Spine is recalling the LIF AMP Adjustable Awl due to an assembly defect preventing the locking feature from engaging. This prevents proper depth control during surgery and risks dural tears, vascular injury, and neurologic damage.

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: This is an FDA Class II recall for a surgical instrument with a manufacturing defect that prevents critical safety mechanisms from functioning. While no injuries have been reported, the potential hazards—dural tears, vascular injury, and neurologic damage—are serious. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The LIF AMP Adjustable Awl (REF 117-165) is a surgical instrument used in lateral interbody fusion of the spine. Alphatec Spine, Inc. is recalling the device due to a manufacturing defect: the drill button assembly may be assembled in an incorrect orientation, preventing the locking feature from properly engaging with the shaft.

This defect prevents the instrument from properly controlling awl insertion depth during surgery. When depth cannot be properly controlled, there is risk of over-insertion, which may cause dural tears (injury to the spinal cord membrane), vascular injuries (blood vessel damage), neurologic injuries, and damage to adjacent tissue. These complications may necessitate revision surgery and prolong operative time.

Approximately 29 units of Lot EM50715 (UDI-DI: 00190376228037) were distributed nationwide across 16 states. Healthcare facilities in Connecticut, Indiana, Texas, Louisiana, Ohio, Alabama, New Hampshire, Massachusetts, North Carolina, Arizona, Maryland, New Jersey, Illinois, California, Utah, and Michigan may be affected.

Facilities that received this device should discontinue use of the recalled lot immediately and contact Alphatec Spine, Inc. for replacement or return instructions.

The recalled product

Product
LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral Interbody Systems, IdentiTi LIF, Transcend LIF and Battalion LLIF,
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical Instrument
Hazard
  • assembly-defect
  • depth-control-failure
  • dural-tear
  • vascular-injury
  • neurologic-injury

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)

  • UDI-DI: 00190376228037
  • Lot: EM50715

Distribution

Distributed nationwide across the United States.

Related recalls

Same category