Z-2729-2024Class II

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

Name: Z-2729-2024 Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling...
Creator: Stryker Corporation
Published: 2024-07-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2024-07-24 / Completed

FDA source

Stryker Corporation began a recall of Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting... on 2024-07-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2729-2024
Classification: Class II
Status: Completed
Initiated: 2024-07-24
Posted: 2024-08-26
Recalling firm: Stryker Corp.
Product: 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
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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 root cause: Under Investigation by firm
Action: 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 [email protected]. 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: GTIN: 07613327501186 Lot Numbers: 22224017 22227017 23087017 23157017 23188017 23342017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2729-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2722-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2723-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2724-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2725-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2726-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2727-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2728-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2729-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2730-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26
Z-2731-2024	Class II	Completed	Voluntary: Firm initiated	2024-09-04	2024-08-26

Product code HBE

K210377Class IIStryker iBur hubs and cutting accessoriesStryker Corporation / cleared 2021-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)