Class 2 Device Recall Disc Preparation instrument

• Date Initiated by Firm: September 14, 2022
• Date Posted: November 08, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0196-2023
• Recall Event ID: 90940
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• 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-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
• Code Information: 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
• Recalling Firm/ Manufacturer: Alphatec Spine, Inc.; 1950 Camino Vida Roble; Carlsbad CA 92008-6505
• For Additional Information Contact: Brian Beireis; 760-494-6739
• Manufacturer 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.
• FDA Determined Cause: No Marketing Application
• Action: On 10/19/2022, the firm initially emailed its customer to inform them that Disc Preparation Instruments were developed, manufactured, and distributed that included an additional feature and the product did not go through the appropriate regulatory Pre-Market filing. Customer are instructed to: 1) Promptly review their inventory to determine if any of the affected product listed above is within their possession. 2) Abstain from sale and/or use and contact Alphatec Spine Customer Service for instructions on how to carry out a product return. All shipping instructions will be provided, including arrangements for product replacement. 3) Fill out the last page of this letter to confirm that they have read this notification and have taken all necessary actions as described in this notification. 4) Return page 4 (signed) of this letter using one of the methods below: -Mail to: Alphatec Spine, Inc., 1950 Camino Vida Roble, Carlsbad, CA 92008 ATTN: Mihir Naik -Email to: QMSCompliance@atecspine.com For questions, contact 1-800-922-1356
• Quantity in Commerce: 42 devices
• Distribution: U.S.: CA O.U.S.: N/A
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.