Home › Orthofix US LLC › SFS
SFS
Orthofix US LLC · Model 55-1099 · UDI-DI 18257200054145
FTY
Prescription
10
510(k) clearances
436
Adverse events
5
Recalls
403
Facilities
Description
CROSS CONN. TEMPLATE 70, 75, & 80MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-05 | SpineFrontier, Inc. | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
| 2010-10-22 | Lemaitre Vascular, Inc. | Box label (Top Part). Lot and Expiration Date information were switched. |
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 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.