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Response Spine System
ORTHOPEDIATRICS CORP. · Model 01-1600-9011 · UDI-DI 00840194444934
KIJ
Prescription
10
510(k) clearances
2,859
Adverse events (2 deaths)
10
Recalls
82
Facilities
Description
4.5/5.0 Power Pedicle Reduction Screw Driver, 140MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
| 2008-10-10 | Stryker Instruments Div. of Stryker Corporation | The handpieces may continue to run even when the trigger is not depressed, which could result in the unintended cutting of bone or soft tissue damage. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.