Stryker iBur 5.0mm Coarse Diamond 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: 8431-013-050DC
- Company
- Stryker Corporation
- Recall Initiated
- July 24, 2024
- Posted
- August 26, 2024
- Recall Number
- Z-2729-2024
- Quantity
- 1171 units
- Firm Location
- Portage, MI
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
Lot / Code Info
GTIN: 07613327501186 Lot Numbers: 22224017 22227017 23087017 23157017 23188017 23342017
Root Cause
Under Investigation by firm
Action Taken
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.