Class II U.S. Food and Drug Administration

Seaspine Orthopedics Corporation Reef TA Inserter recall: Inserter, used as part of a system with an intervertebral body fusion device

Recall published 1+ years ago

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2554-2025
Published
September 17, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Seaspine Orthopedics Corporation
Product type
Medical devices
Units affected
74
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2
UPC codes
10889981290733

Products covered by this recall

Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

Check your product

The notice names 8 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10889981290733

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • BT107376C
  • BT112289C
  • BT112779C
  • BT107376CR1
  • BT107376CR2
  • BT107376CR1R

Model or item number

On the rating label, the box or the instruction sheet.

  • TA2-001003

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Seaspine Orthopedics Corporation — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: SEASPINE ORTHOPEDICS CORPORATION — 5770 Armada Dr, Carlsbad, CA, 92008-4608

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Seaspine Orthopedics Corporation medical devices recalled?

Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking. Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10889981290733; lot code BT107376C, BT112289C, BT112779C; model number TA2-001003. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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