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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 1.2mm Cross Cut Fissure

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 Class 2 Device Recall Stryker 1.2mm Cross Cut Fissuresee related information
Date Initiated by FirmSeptember 05, 2024
Date PostedOctober 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0063-2025
Recall Event ID 95342
510(K)NumberK143320 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product1.2mm 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
Code Information GTIN: 04546540362346 Lot number: 22329017
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactSAME
269-800-1941
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionStryker 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.
Quantity in Commerce307 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Columbia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HBE
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