The Recall Desk
ModerateFDA (Devices)·Z-0196-2023·Announced 2022-11-16

Alphatec Spine Disc Preparation Instruments Recalled for Regulatory Non-Compliance

Alphatec Spine, Inc. is recalling 42 disc preparation surgical instruments due to manufacturing modifications that lacked proper regulatory clearance. The recall is limited to California.

What this means for you

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: This is a FDA Class II recall involving regulatory non-compliance in the manufacturing process. No adverse events, illnesses, injuries, or deaths are reported in the source documentation. The recall is a preventive action due to inadequate regulatory consideration of design modifications, making it a moderate-severity manufacturing and compliance issue.

Plain-English summary

Alphatec Spine, Inc. is recalling 42 disc preparation instruments used in spine surgery procedures. The recalled products include Longer IdentiTi PO Trial Tips, Longer Rotating Disc Shavers, and Longer Curettes in various sizes and configurations.

The instruments are being recalled because the manufacturer added additional features to the devices without submitting the required regulatory notification to the FDA. The manufacturing changes were not adequately evaluated for their regulatory implications, potentially affecting the cleared specifications of the devices.

The recall affects healthcare facilities that received these instruments in California. Healthcare providers should identify any recalled instruments in their inventory and take them out of service.

Anyone who has received or used these recalled instruments should contact Alphatec Spine, Inc. for further guidance on handling, destruction, or replacement of the affected devices.

The recalled product

Product
Disc Preparation instruments contained in the following products: CI-11050-08102515 Longer IdentiTi PO Trial Tip, 11A X 8P X 10 X 25mm, 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip, 12A X 9P X 10 X 25mm, 15¿ TC11050 00840180510827 CI-1105
Manufacturer
Alphatec Spine, Inc.
Category
Medical Device — Surgical instruments
Hazard
  • manufacturing-defect
  • unvalidated-design-change

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 (20)

  • 11A X 8P X 10 X 25mm
  • 15¿ TC11050 00840180510810 CI-11050-09102515 Longer IdentiTi PO Trial Tip
  • 12A X 9P X 10 X 25mm
  • 15¿ TC11050 00840180510827 CI-11050-10102515 Longer IdentiTi PO Trial Tip
  • 13A X 10P X 10 X 25mm
  • 15¿ TC11050 00840180510834 CI-11050-11102515 Longer IdentiTi PO Trial Tip
  • 14A X 11P X 10 X 25mm
  • 15¿ TC11050 00840180510841 CI-11050-12102515 Longer IdentiTi PO Trial Tip
  • 15A X 12P X 10 X 25mm
  • 15¿ TC11050 00840180510858 CI-11051-10-07 Longer Rotating Disc Shaver
  • Parallel
  • 7mm TC11051 00840180511084 CI-11051-20-13 Longer Rotating Disc Shaver
  • 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver
  • 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver
  • 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver
  • 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver
  • 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver
  • 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver
  • 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver
  • 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver

Distribution

Distributed in 1 state:

  • CA

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