Drug recall
Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling…
FDA recall event 95040 · Class II · Stryker Corporation
Key facts
| Event ID | 95040 |
|---|---|
| Recall numbers | Z-2722-2024, Z-2723-2024, Z-2724-2024, Z-2725-2024, Z-2726-2024, Z-2727-2024, Z-2728-2024, Z-2729-2024, Z-2730-2024, Z-2731-2024 |
| Recalling firm | Stryker Corporation |
| Product type | Devices |
| Products | Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical…, Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following…, Stryker iBur 3.0mm Diamond Match Head, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following…, Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical…, Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following… and 5 more |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jul 24, 2024 |
| Report date | Sep 4, 2024 |
| City | Portage |
| State | MI |
| Country | United States |
| FEI number | 3015967359 |
At a glance
- 10–99 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: