Stryker iBur 4 — Class II medical device recall Z-2728-2024
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-2728-2024 |
|---|---|
| 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 | 5,031 units |
| UPC / GTIN / UDI-DI | 07613327501155 |
| Lot numbers | 22248017, 22263017, 22334017, 22348017, 22348027, 23016027, 23095027, 23128017, 23163017, 23179017, 23205017, 23205027, 23205037, 23221017, 23311017, 24004017, 24004027, 24004037 |
| Model numbers | 8431-013-040DC |
Product
Stryker iBur 4.0mm 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: 8431-013-040DC
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-2728-2024. 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.