FDA Medical devices recall ·
1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling… recall
- Recall number
- Z-0063-2025
- Date
- (initiated September 5, 2024)
- Company / brand
- Stryker Corporation
1941 Stryker Way, Portage, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 307 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 04546540362346 Lot number: 22329017
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0063-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.