Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, de

FDA device recall Z-2729-2024 · posted 2024-08-26 · Completed

Recall details

Recalling firm

Stryker Corporation

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.

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.

Root cause

Under Investigation by firm

Status

Completed

Product code

HBE

Quantity affected

1171 units

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.

Date initiated

2024-07-24

Date posted

2024-08-26

Location

Portage, MI

Related 510(k) clearances