1.2mm Cross Cut Fissure - Intended for use in the recall: Endotoxin
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…
Why was 1.2mm Cross Cut Fissure - Intended for use in the 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 04546540362346 Lot number: 22329017
- 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…
- Recalling firm
- Stryker Corporation
- Quantity
- 307 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Columbia.
- Recall date
- October 23, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)