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DELTA
Stryker Leibinger GmbH & Co. KG · Model 70-92032 · UDI-DI 07613252598190
DZJ
Prescription
1
510(k) clearances
3,399
Adverse events (1 deaths)
11
Recalls
48
Facilities
Description
S-DRILLING TAP, HEX, FOR 4mm SCREW
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-17 | Medical Modeling, Inc. | Scapula Marking Guide (anatomically Shaped) was incorrectly designed. |
| 2013-10-02 | Stryker Instruments Div. of Stryker Corporation | It 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 |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There 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 |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There 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 |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There 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 |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There 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 |
| 2011-10-18 | Stryker Instruments Div. of Stryker Corporation | There 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 |
| 2006-01-30 | Straumann Manufacturing Inc. | Pilot drills may not fully extend through drill guide in template products |
| 2006-01-30 | Straumann Manufacturing Inc. | Pilot drills may not fully extend through drill guide in template products |
| 2005-08-05 | Stryker Instruments Div. of Stryker Corporation | Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current. |
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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.