🔍 RecallPedia

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-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, Parallel, 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm TC11051 00840180511060 CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm TC11051 00840180511138 CI-11052-01-022-05 Longer Straight Curette, Size 2 TC11052 00840180511282 CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 TC11052 00840180511299 CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 TC11052 00840180511305 CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 TC11052 00840180511312 CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 TC11071 00840180511275

Class I - Dangerous
🏥 Medical Devices Recalled: September 14, 2022 Alphatec Spine Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Part Number/Description/Lot Number/UDI-DI(GTIN): 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-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, Parallel, 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm TC11051 00840180511060 CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm TC11051 00840180511138 CI-11052-01-022-05 Longer Straight Curette, Size 2 TC11052 00840180511282 CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 TC11052 00840180511299 CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 TC11052 00840180511305 CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 TC11052 00840180511312 CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 TC11071 00840180511275
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Alphatec Spine, Inc.
Reason for Recall:
Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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-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, Parallel, 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm TC11051 00840180511060 CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm TC11051 00840180511138 CI-11052-01-022-05 Longer Straight Curette, Size 2 TC11052 00840180511282 CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 TC11052 00840180511299 CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 TC11052 00840180511305 CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 TC11052 00840180511312 CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 TC11071 00840180511275

Product Codes/Lot Numbers:

Part Number/Description/Lot Number/UDI-DI(GTIN): 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-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, Parallel, 13mm TC11051 00840180511145 CI-11051-20-15 Longer Rotating Disc Shaver, Parallel, 15mm TC11051 00840180511169 CI-11051-20-09 Longer Rotating Disc Shaver, Parallel, 9mm TC11051 00840180511107 CI-11051-20-08 Longer Rotating Disc Shaver, Parallel, 8mm TC11051 00840180511091 CI-11051-20-11 Longer Rotating Disc Shaver, Parallel, 11mm TC11051 00840180511121 CI-11051-10-06 Longer Rotating Disc Shaver, Parallel, 6mm TC11051 00840180511077 CI-11051-20-10 Longer Rotating Disc Shaver, Parallel, 10mm TC11051 00840180511114 CI-11051-20-14 Longer Rotating Disc Shaver, Parallel, 14mm TC11051 00840180511152 CI-11051-10-05 Longer Rotating Disc Shaver, Parallel, 5mm TC11051 00840180511060 CI-11051-20-12 Longer Rotating Disc Shaver, Parallel, 12mm TC11051 00840180511138 CI-11052-01-022-05 Longer Straight Curette, Size 2 TC11052 00840180511282 CI-11052-02-022-05 Longer Up-Angled Pull Curette, Size 2 TC11052 00840180511299 CI-11052-04-022-05 Longer Right-Angled Pull Curette, Size 2 TC11052 00840180511305 CI-11052-05-022-05 Longer Left-Angled Curette, Size 2 TC11052 00840180511312 CI-11071-021-05 Longer Straight Teardrop Curette, Size 2 TC11071 00840180511275

Distribution:

Distributed in: CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0196-2023

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