FDA Device Intelligence
Home › Shalby Advanced Technologies, Inc. › Revision Knee System

Revision Knee System

Shalby Advanced Technologies, Inc. · Model 2970-0-0027 · UDI-DI 00840286842068

KIJ Prescription
10
510(k) clearances
2,860
Adverse events (2 deaths)
10
Recalls
82
Facilities

Description

RKS, Stop Drill Bit, .25 OD x .50 Dp, SS

Recalls

DateFirmReason
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.
2008-10-10Stryker Instruments Div. of Stryker CorporationThe 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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.