Stryker iBur 4.0mm Precision Round, Distal Bend- intended... (Stryker Corporation) – potential for the product to exhibit ... (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker iBur 4.0mm Precision Round, 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: 8431-009-040
Brand
Stryker Corporation
Lot Codes / Batch Numbers
GTIN: 07613327501223 Lot Numbers: 22245017 22248017 22270017 22299017 22306027 23188017
Products Sold
GTIN: 07613327501223 Lot Numbers: 22245017 22248017 22270017 22299017 22306027 23188017
Stryker Corporation is recalling Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the following manner: drill due to Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than spe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Stryker 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026