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MEDTRONIC SOFAMOR DANEK, INC. · Model 9870014 · UDI-DI 00613994284792
HWJ
Prescription
4
510(k) clearances
313
Adverse events
26
Recalls
321
Facilities
Description
DRIVER 9870014 TEMPORARY AWL TACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-04 | SEASPINE ORTHOPEDICS CORPORATION | Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. |
| 2023-07-07 | Alphatec Spine, Inc. | Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments la |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
| 2020-04-13 | K2M, Inc | The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure. |
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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.