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RONDO'
CITIEFFE SRL · Model Screw ø4mm L60mm · UDI-DI 08032909622467
1
510(k) clearances
2,868
Adverse events (1 deaths)
32
Recalls
280
Facilities
Description
Titanium cannulated screw ø4mm L60mm with washer. Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-23 | Arrowhead DE LLC | Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audi |
| 2024-07-09 | Smith & Nephew, Inc. | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contain |
| 2024-07-09 | Smith & Nephew, Inc. | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contain |
| 2022-05-26 | Paragon 28, Inc. | Due to Titanium plasma coating not present implant. |
| 2022-03-28 | Stryker GmbH | The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead |
| 2022-01-28 | Brasseler USA, Medical L.L.C. | One lot of product was distributed in unsealed packaging |
| 2019-12-11 | Brasseler USA I Lp | 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tub |
| 2019-11-04 | Trilliant Surgical, LLC | The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should |
| 2018-05-16 | Zimmer Biomet, Inc. | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail |
| 2018-05-16 | Zimmer Biomet, Inc. | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail |
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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.