Class II FDA device recall · Z-1182-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm 132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm 132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm 232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm 232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm 232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm The IdentiTi ALIF Standalone Interbody System is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (ALIF) procedures.

Why it was recalled

Due to reports of intraoperative graft bolt implantation breakages.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Part Number / Product Description / UDI-DI Code / Lot Number 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376299716 Lot Numbers: 8746709, 8746724, TO00212  132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376299730 Lot Numbers: 8746710, 8746725, TO00213  132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376299754 Lot Numbers: 8746711, TO00218  132-10-90-250 / IdentiTi ALIF SA Graft Bolt, 09 x 25 mm UDI-DI code: 00190376299792 Lot Numbers: 8746712  132-10-90-300 / IdentiTi ALIF SA Graft Bolt, 09 x 30 mm UDI-DI code: 00190376299815 Lot Numbers: 6746713  132-10-90-350 / IdentiTi ALIF SA Graft Bolt, 09 x 35 mm UDI-DI code: 00190376299839 Lot Numbers: 8746714  232-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm UDI-DI code: 00190376369976 Lot Numbers: TO00373, TO00670, TO00694, TO00834, TO01038, TO01404, TO01514, TO01572, TO01573, TO01696, TO01974, TO01979, TO01982, TO02297, TO02393, TO03218, TO03465  232-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm UDI-DI code: 00190376369990 Lot Numbers: TO00376, TO00671, TO00695, TO00710, TO00835, TO01039, TO01405, TO01515, TO01574, TO01575, TO01697, TO01975, TO01980, TO01983, TO02298, TO02394, TO03219, TO03466  232-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm UDI-DI code: 00190376370019 Lot Numbers: TO00380, TO00672, TO00696, TO00836, TO01576, TO01577, TO02163, TO02395  232-11-90-250 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 25 mm UDI-DI code: 00190376370293 Lot Numbers: TO00381, TO00673, TO00697, TO01277, TO01578, TO02396  232-11-90-300 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 30 mm UDI-DI code: 00190376370316 Lot Numbers: TO00382, TO00674, TO00698, TO01040, TO01406, TO02164, TO02397, TO03220  232-11-90-350 / IdentiTi ALIF SA Cannulated Graft Bolt, 09 x 35 mm UDI-DI code: 00190376370330 Lot Numbers: TO00383, TO00699, TO01407, TO02398

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand.

Recall record

Recalling firm: Alphatec Spine, Inc.
Product type: Devices
Recall number: Z-1182-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Carlsbad, CA
Recall initiated: 2024-01-26

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1182-2024 · Source: openFDA enforcement.