CLASS II ONGOING Device recall · Reported 17 Sep 2025 · FDA Enforcement Report

Reef TA Inserter recalled by Seaspine Orthopedics

Seaspine Orthopedics is recalling Reef TA Inserter, distributed nationwide in the US. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2

Quantity recalled74

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2554-2025
FDA event ID: 97190
Recalling firm: Seaspine Orthopedics, Carlsbad, CA
Classification: Class II
Status: Ongoing
Recall initiated: 6 Aug 2025
FDA classified: 11 Sep 2025
Reported: 17 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Spinal Implants

Timeline

6 Aug 2025	Recall initiated by company
11 Sep 2025	Classified by FDA	+36 days
17 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.

Nationwide Colorado Connecticut Florida Idaho Michigan Minnesota North Carolina Nevada Ohio Oklahoma Pennsylvania South Dakota Tennessee Texas Washington

Questions about this recall

Is Reef TA Inserter recalled?

Yes. Seaspine Orthopedics recalled Reef TA Inserter on 6 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2554-2025.

Why was it recalled?

Which lots are affected?

UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2

Where was it sold?

Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Seaspine Orthopedics

All 10

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	SeaSpine Polyaxial Head recalled by Seaspine Orthopedics	Seaspine Orthopedics	Other	Nationwide
24 Dec 2025Device	CLASS II	Orthofix NorthStar OCT Navigation Surgical Technique Guide recalled	Seaspine Orthopedics	Lead & Heavy Metals	24 states
1 Jan 2025Device	CLASS II	Daytona Small Stature Ti Locking Cap, Small Stature, T25 recalled	Seaspine Orthopedics	Device Malfunction	Nationwide
1 Jan 2025Device	CLASS II	Daytona Small Stature CoCr LockingCap, Small Stature, T25, BT recalled	Seaspine Orthopedics	Device Malfunction	Nationwide
24 Jul 2024Device	CLASS II	Meridian Angled Awl Fixed Angled Awl Fixed recalled	Seaspine Orthopedics	Other	18 states

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