Stryker Corporation: Medical Device Recall in 2024 - (Recall #: Z-0063-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012

Product Classification:

Class II

Date Initiated: September 5, 2024

Date Posted: October 23, 2024

Recall Number: Z-0063-2025

Event ID: 95342

Reason for Recall:

May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.

Status: Ongoing

Product Quantity: 307 units

Code Information:

GTIN: 04546540362346 Lot number: 22329017

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, Columbia.

Voluntary or Mandated:

Voluntary: Firm initiated