Home › Device types › HSB
Rod, Fixation, Intramedullary And Accessories
FDA product code HSB · Class 2 · Orthopedic
38,561
Registered devices
37,471
Adverse events
690
Recalls
530
510(k) clearances
Devices with this code
ZERO Profile Interlocking Cortex Screw, 3.5mm x 30mm, T15, Flex-Thread™ — FLOWER ORTHOPEDICS CORPORATIONGPC — GPC MEDICAL LIMITEDGPC — GPC MEDICAL LIMITEDCORTICAL BONE SCREW, SELF-TAPPING — Biomet Orthopedics, LLCAffixus® — Zimmer, Inc.AUTOBAHN — GLOBUS MEDICAL, INC.AUTOBAHN — GLOBUS MEDICAL, INC.Panta® 2 — Ascension Orthopedics, Inc.CHIMAERA Hip Fracture System — ORTHOFIX SRLPediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.ORTHOFIX — ORTHOFIX SRLPhoenix Antegrade Nail System — Biomet Orthopedics, LLCPediatric Nailing Platform | Tibia — ORTHOPEDIATRICS CORP.Retrograde Femoral Nail — Auxein Medical Private LimitedNA — SYNTHES (U.S.A.) LPORTHOFIX — ORTHOFIX SRLT2 — Stryker GmbHPHOENIX TIBIAL NAIL SYSTEM — Biomet Orthopedics, LLCPNP Femur — ORTHOPEDIATRICS CORP.T2 — Stryker GmbHTFN-ADVANCE — Synthes GmbHORTHOFIX — ORTHOFIX SRLAOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.DYNAMIC TIBIAL NAIL — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-16 | Smith & Nephew, Inc. | Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
| 2025-12-02 | Zimmer, Inc. | Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant |
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