Z-2554-2025Class II

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

Name: Z-2554-2025 Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Creator: Seaspine Orthopedics Corporation
Published: 2025-08-06
License: https://open.fda.gov/license/

SeaSpine Orthopedics Corporation / initiated 2025-08-06 / Open, Classified / root cause: design

FDA source

SEASPINE ORTHOPEDICS CORPORATION began a recall of Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System on 2025-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2554-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-06
Posted: 2025-09-11
Recalling firm: SeaSpine Orthopedics Corporation
Product: Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 8/6/2025, recall notices were emailed to customers and distributors who were informed of the following: A laser marking error was identified in which the TA2-001003 inserters were incorrectly marked with the UDI-DI for model TA2-001002 (10889981290733). Updated Revision E Inserters have been shipped to you via overnight delivery. Kindly replace all existing Revision C/R1/R2 Inserters with the enclosed Revision E units. Return the Revision C Inserters to the recalling firm using provided RGA and prepaid shipping label. This recall notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Should you have any questions regarding this matter, please contact the firm at: [email protected]
Quantity in commerce: 74
Distribution: 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.
Product codes and lots: UDI-DI: 10889981290733, 10889981437800. Lots: BT107376C, BT112289C, BT112779C, BT107376CR1, BT107376CR2, BT107376CR1R2, BT112289CR2, BT112779CR2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2554-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2554-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-17	2025-09-11

Product code MAX

K192132Class IISeaSpine Beachside SystemSeaSpine Orthopedics Corporation / cleared 2019-12-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)