Stryker iBur 5 — Class II medical device recall Z-2729-2024

Completed recall by Stryker Corporation, reported 2024-09-04, distributed nationwide. Potential for the product to exhibit temperatures higher than specification where the bur shank meets the dist

Recall number	`Z-2729-2024`
Product type	Medical device
Classification	Class II
Status	Completed
Voluntary or mandated	Voluntary
Recalling firm	Stryker Corporation, Portage, MI, United States
Recall initiated	2024-07-24
Classified	2024-08-26
Reported by FDA	2024-09-04
Distributed	Nationwide (US)
Countries outside the US	AU, CA, ES, FR, GB, HK, IN, IT, JP, KR, NL, SE, TW
Quantity	1,171 units
UPC / GTIN / UDI-DI	`07613327501186`
Lot numbers	`22224017`, `22227017`, `23087017`, `23157017`, `23188017`, `23342017`
Model numbers	`8431-013-050DC`

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2729-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.