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DELTA

Stryker Leibinger GmbH & Co. KG · Model 70-92031 · UDI-DI 07613252598183

DZJ Prescription
1
510(k) clearances
3,399
Adverse events (1 deaths)
11
Recalls
48
Facilities

Description

S-DRILLING TAP, HEX, FOR 5/6mm SCREW

Recalls

DateFirmReason
2022-05-17Medical Modeling, Inc.Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
2013-10-02Stryker Instruments Div. of Stryker CorporationIt was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide
2011-10-18Stryker Instruments Div. of Stryker CorporationThere is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being
2011-10-18Stryker Instruments Div. of Stryker CorporationThere is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being
2011-10-18Stryker Instruments Div. of Stryker CorporationThere is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being
2011-10-18Stryker Instruments Div. of Stryker CorporationThere is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being
2011-10-18Stryker Instruments Div. of Stryker CorporationThere is a potential for these blades to break where the blade is welded on to the arbor. This hazard can result in the following harms: tissue damage due to the broken blade being
2006-01-30Straumann Manufacturing Inc.Pilot drills may not fully extend through drill guide in template products
2006-01-30Straumann Manufacturing Inc.Pilot drills may not fully extend through drill guide in template products
2005-08-05Stryker Instruments Div. of Stryker CorporationPotential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.

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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.