Home › Device types › HXK
Holder, Needle; Orthopedic
FDA product code HXK · Class 1 · Orthopedic
3,112
Registered devices
114
Adverse events
5
Recalls
5
510(k) clearances
Devices with this code
gSource — GSOURCE LLCN/A — BIOMET MICROFIXATION, INCNovo Surgical Inc. — NOVO SURGICAL, INC.Anmuth Medical International — Anmuth Medical International, LLCBMT Medizintechnik GmbH — BMT Medizintechnik GmbHBMT Medizintechnik GmbH — BMT Medizintechnik GmbHORTHOMED — ORTHO-MED, INC.PIN HOLDER — Biomet Orthopedics, LLCBuxton BioMedical — Buxton Biomedical IncNA — Fehling Instruments GmbH & Co. KGNA — Fehling Instruments GmbH & Co. KGSklar® — SKLAR CORPORATIONSklar® — SKLAR CORPORATIONSymmetry Classic Plus® Crile-Wood — ASPEN SURGICAL PRODUCTS, INC.PILLING — TELEFLEX INCORPORATEDgSource — GSOURCE LLCgSource — GSOURCE LLCSklar® — SKLAR CORPORATIONSklar® — SKLAR CORPORATIONORTHOMED — ORTHO-MED, INC.Trinity Sterile, Inc. — Trinity Sterile, Inc.Sklar® — SKLAR CORPORATIONNEEDLE HOLDER — KLS-Martin L.P.ZOLL-DENTAL — Zoll-Dental
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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