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Pediatric Nailing Platform | Tibia

ORTHOPEDIATRICS CORP. · Model 01-1510-0008 · UDI-DI 00840194428835

KIJ Prescription

510(k) clearances

2,859

Adverse events (2 deaths)

Recalls

Facilities

Description

Conical Reamer, 9.75mm, Long

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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Data 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.