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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker iBur hubs and cutting accessories

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 Class 2 Device Recall Stryker iBur hubs and cutting accessoriessee related information
Date Initiated by FirmJuly 24, 2024
Date PostedAugust 26, 2024
Recall Status1 Completed
Recall NumberZ-2731-2024
Recall Event ID 95040
510(K)NumberK210377 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductStryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-107-530
Code Information GTIN: 07613327501193 Lot Numbers: 22228017 22257017 22269017 22276017 23085017 23095017 23157017 23157027 23179017 23179027 23198017 23213017 23221017 23299017 23345017 23345027
FEI Number 3015967359
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information ContactSAME
269-800-1941
Manufacturer Reason
for Recall		Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker issued Urgent Medical Device Recall letter on 7/24/424 to Materials Manager, Risk Manager, OR Director via Fed'x. Letter states reason for recall, health risk, and action to take: 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 credit 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 by phone (269) 568-1481 or email at Instruments.Recalls@stryker.com.
Quantity in Commerce3673 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
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.
510(K) Database510(K)s with Product Code = HBE
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