IPP-ON
NEWDEAL · Model 230001SND · UDI-DI 10381780045892
HTY
Prescription
1
510(k) clearances
2,889
Adverse events (1 deaths)
32
Recalls
279
Facilities
Description
The Newdeal Interphalangeal implant is designed to respect anatomical flexion to achieve fixation of interphalangeal arthrodesis of the lesser toes in case of rigid or semi-rigid hammertoe deformity, revision of failed arthroplasty or arthrodesis, and shortening due to length excess of the second toe. The implant configuration is available in two different sizes and is manufactured from Stainless Steel. It is delivered sterile.
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.