SchurSign
SurgMark GmbH · Model SchurSign 1.5-5 · UDI-DI 04262491960003
Description
SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location. SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate. SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker. The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-24 | Devicor Medical Products Inc | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. |
| 2026-01-21 | Stryker Corporation | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedure |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2025-10-01 | ENDOMAGNETICS LTD | Potential for contamination with cotton fibers. |
| 2024-11-18 | Elucent Medical Inc | There is a potential safety risk caused by physical disassociation of the back section from the bed frame of Skytron model series 3600, 6500, 6600 and 6700 operating room beds when |
| 2024-10-10 | Hologic, Inc | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. |
| 2024-03-13 | Hologic, Inc | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complication |
| 2022-12-16 | Carbon Medical Technologies, Inc. | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shap |
| 2022-08-09 | Hologic, Inc | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expirat |
| 2022-03-30 | Devicor Medical Products Inc | Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectl |
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