Home › Device types › HXK
Holder, Needle; Orthopedic
FDA product code HXK · Class 1 · Orthopedic
3,124
Registered devices
115
Adverse events
5
Recalls
5
510(k) clearances
Devices with this code
N/A — BIOMET MICROFIXATION, INCMarina Medical — MARINA MEDICAL INSTRUMENTS, INC.Sklar® — SKLAR CORPORATIONSklar — SKLAR CORPORATIONNEEDLE HOLDER — KLS-Martin L.P.gSource — GSOURCE LLCNovo Surgical Inc. — NOVO SURGICAL, INC.LINK Instruments - Forceps — WALDEMAR LINK GmbH & Co. KGZOLL-DENTAL — Zoll-DentalHexanium® ACIF — SPINEVISIONDIADUST — Aesculap AGLOSPA IS Spinal System — Corentec Co., LtdNEEDLE HOLDER — KLS-Martin L.P.ORTHOMED — ORTHO-MED, INC.Sklar® — SKLAR CORPORATIONJEDMED — JEDMED INSTRUMENT COMPANYInnomed, Inc. — INNOMED, INC.NEEDLE HOLDER — KLS-Martin L.P.Brasseler USA — Peter Brasseler Holdings, LLCNEEDLE HOLDER — KLS-Martin L.P.NEEDLE HOLDER — KLS-Martin L.P.Anmuth Medical International — Anmuth Medical International, LLCORTHOMED — ORTHO-MED, INC.NA — Fehling Instruments GmbH & Co. KG
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2023-05-18 | Aesculap Implant Systems LLC | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. |
| 2020-08-17 | ArthroCare Corporation | Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as oppo |
| 2019-09-25 | Aesculap Implant Systems LLC | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. |
| 2011-11-08 | DePuy Orthopaedics, Inc. | DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This |
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