STILLE Osteotomes
Stille AB · Model 100-111-0084 · UDI-DI 07332339232948
10
510(k) clearances
16
Adverse events
14
Recalls
87
Facilities
Description
HAND OSTEOTOME STILLE 12 mm curved blade R45 mm phenolic handle 16 cm 6.25 in
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-11 | AAP Implantate Ag | There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate. |
| 2018-03-15 | Zimmer GmbH | Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
| 2017-03-30 | Smith & Nephew, Inc. | The stability data does not support the product labeled with a 10-year shelf life. |
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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.