1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bo

FDA device recall Z-0063-2025 · posted 2024-10-11 · Open, Classified

Recall details

Recalling firm

Stryker Corporation

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

HBE

Quantity affected

307 units

Distribution

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

Date initiated

2024-09-05

Date posted

2024-10-11

Location

Portage, MI

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