ModerateClass IIOngoing

FDA Devices recall · Reported November 16, 2022

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0196-2023.

Q: Where was the recalled product distributed?

Distribution: U.S.: CA O.U.S.: N/A.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0196-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.

Recall #: Z-0196-2023
Affected scope: 42 devices
Initiated: September 14, 2022

Compiled from official public sources by the editorial team.

Verify with FDA Devices →

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Alphatec Spine, Inc. recalled Disc Preparation instruments contained in the following products: CI-11050-08102515 Lon… - a moderate-severity action.

Disc Preparation instruments contained in the following products: CI-11050-08102515 Lon… was recalled by Alphatec Spine, Inc. in November 16, 2022. Reason: Due to manufacturing instruments which included additional features and adequate consideration was not given …. Check the official notice for the remedy. Verify recall #Z-0196-2023 with the FDA Devices before acting.

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The recall

Alphatec Spine, Inc. issued this moderate-severity FDA Devices recall — Due to manufacturing instruments which included additional features and adequate consideration was not given ….

Moderate
severity level: 42 units
affected scope: Class II
classification: November 16, 2022
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0196-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0196-2023) was formally reported on November 16, 2022, with the manufacturer initiating the action on September 14, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Alphatec Spine, Inc. is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 42 devices.

The documented reason for this recall is: Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing. Distribution data in the federal record shows the product reached: U.S.: CA O.U.S.: N/A. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

42 devices

Related Recalls

6 from same agency

Product 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

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0196-2023
Date reported	November 16, 2022
Date initiated	September 14, 2022
Recalling firm	Alphatec Spine, Inc.
Firm location	Carlsbad, CA
Affected scope	42 devices
Distribution	U.S.: CA O.U.S.: N/A

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

42 devices units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0196-2023) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting — recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Due to manufacturing instruments which included additional features and adequate consideration was not given to the need for a new Regulatory filing.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 16, 2022. Severity: Moderate. Recall number: Z-0196-2023.

Where was the recalled product distributed? ▼

Distribution: U.S.: CA O.U.S.: N/A.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0196-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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What to do next

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported November 16, 2022.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.