—#210037

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

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K143320
Affected lot / code info: GTIN: 04546540362346 Lot number: 22329017

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Corporation
Address: 1941 Stryker Way, Portage, Michigan 49002-9711

Distribution

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

Timeline

Recall initiated: 2024-09-05
Posted by FDA: 2024-10-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210037. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.