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K-WIRE

NEWDEAL · Model 115171ND · UDI-DI 10381780045809

HTY Prescription

510(k) clearances

2,868

Adverse events (1 deaths)

Recalls

280

Facilities

Description

The NEWDEAL K-WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion. They are made out of stainless steel and are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants.

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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Data 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.