Home › Device types › HTY
Pin, Fixation, Smooth
FDA product code HTY · Class 2 · Orthopedic
10,327
Registered devices
2,903
Adverse events
32
Recalls
205
510(k) clearances
Devices with this code
FULLY THREADED CORTICAL SCREW — Biomet Orthopedics, LLCRONDO' — CITIEFFE SRLThreaded K-wire,15mm thread,2.0x150mm, trocar/round — mahe medical gmbhSOLID CANCELLOUS SCREW — Biomet Orthopedics, LLCVERSANAIL®UNIVERSAL FEMORAL NAIL — Biomet Orthopedics, LLCBROAD SELF - COMPRESSING PLATE — Biomet Orthopedics, LLCSM K-WIRES — Peter Brasseler Holdings, LLCPedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.NA — Synthes GmbHTRAUMA FIXATION SYSTEMS — Biomet Orthopedics, LLCMONDEAL — MONDEAL Medical Systems GmbHPOLYAX®LOCKING CORTICAL SCREW — Biomet Orthopedics, LLCPedFlex Flexible Nailing System — ORTHOPEDIATRICS CORP.mahe medical GmbH — mahe medical gmbhFULLY THREADED CORTICAL SCREW — Biomet Orthopedics, LLCA.L.P.S.® — Biomet Orthopedics, LLC6 HOLE LOCKING DISTAL TIBIA MEDIAL PLATE — Biomet Orthopedics, LLCRONDO' — CITIEFFE SRLNA — Zimmer, Inc.NA — STRYKER CORPORATIONLOCKING DISTAL TIBIA MEDIAL PLATE, LEFT — Biomet Orthopedics, LLCRONDO' — CITIEFFE SRLNA — aap Implantate AGTRAUMA FIXATION SYSTEM — Biomet Orthopedics, LLC
Recent 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 |
| 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 th |
| 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 th |
| 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 |
| 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 prod |
| 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 |
| 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 |
| 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 |
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