SeaSpine Polyaxial Head REF Number: 41-3010 recall — FDA Z-2762-2026
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Overview of recall records associated with SEASPINE ORTHOPEDICS CORPORATION, including dates, categories and classifications where available.
Classification mix: Class II: 10.
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
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…
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…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
This page summarizes recall records in which the official source identifies SEASPINE ORTHOPEDICS CORPORATION as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.