Drug recall
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final…
FDA recall event 69784 · Class II · Stryker Spine
Key facts
| Event ID | 69784 |
|---|---|
| Recall numbers | Z-0803-2015 |
| Recalling firm | Stryker Spine |
| Product type | Devices |
| Products | Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery. |
| Initiation date | Oct 6, 2014 |
| Report date | Dec 24, 2014 |
| Termination date | May 8, 2017 |
| City | Allendale |
| State | NJ |
| Country | United States |
| FEI number | 3004024955 |
At a glance
- 1–9 Products in this recall
- 10–99 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: