SEASPINE ORTHOPEDICS CORPORATION: Device Recall

Recall Details

Recall Number

Z-0751-2025

Classification

Class II

Product Type

Device

Recalling Firm

SEASPINE ORTHOPEDICS CORPORATION

Status

Ongoing

Date Initiated

10/29/2024

Location

Carlsbad, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

92 devices

Reason for Recall

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Product Description

Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No

Distribution Pattern

U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.

Other Recalls by SEASPINE ORTHOPEDICS CORPORATION

• Class II: Risk 11/17/2025
  The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
• Class II: Risk 08/06/2025
  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.
• Class II: Risk 10/29/2024
  Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
• Class II: Risk 06/04/2024
  Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
• Class II: Risk 05/17/2024
  Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

View all recalls by SEASPINE ORTHOPEDICS CORPORATION →