FDA Device Intelligence
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Pin, Fixation, Smooth

FDA product code HTY · Class 2 · Orthopedic

10,262
Registered devices
2,868
Adverse events
32
Recalls
204
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-23Arrowhead DE LLCImplant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma
2024-07-09Smith & 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 th
2024-07-09Smith & 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 th
2022-05-26Paragon 28, Inc.Due to Titanium plasma coating not present implant.
2022-03-28Stryker GmbHThe nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel
2022-01-28Brasseler USA, Medical L.L.C.One lot of product was distributed in unsealed packaging
2019-12-11Brasseler USA I Lp103 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 prod
2019-11-04Trilliant Surgical, LLCThe 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
2018-05-16Zimmer 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
2018-05-16Zimmer 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.