1.2mm Cross Cut Fissure (Stryker) – Endotoxin Risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Stryker Corporation
Lot Codes / Batch Numbers
GTIN: 04546540362346 Lot number: 22329017
Products Sold
GTIN: 04546540362346 Lot number: 22329017
Stryker Corporation is recalling 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shapin due to May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Stryker issued Urgent Medical Device Recall Letter on 9/5/24 via FedEx 2-day to Recall Department, Materials Manager, OR Director, Risk Manager. Letter states reason for recall, health risk and action to take: Actions needed 1. Immediately review your inventory to locate and quarantine any affected products at your facility. 2. Return the enclosed Business Reply Form (BRF), even if the affected product is no longer in inventory, to the email Instruments.Recalls@stryker.com. 3. Upon receipt of the completed BRF, Stryker will provide a shipping label to return recalled product on-hand. 4. A replacement will be provided upon receipt of the recalled product. 5. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. If you have any questions about this matter, contact Stryker Instruments recall team directly by calling (269) 568-1481 or email at Instruments.Recalls@stryker.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026