Home › Device types › HST
Apparatus, Traction, Non-Powered
FDA product code HST · Class 1 · Orthopedic
353
Registered devices
519
Adverse events
11
Recalls
38
510(k) clearances
Devices with this code
N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.ALLEN — HILL-ROM, INC.Radlink GPS Bucky Cart — RADLINK, INC.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Arthrex® — ARTHREX, INC.CONMED — Conmed CorporationN/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.ACUMED — Acumed LLCN/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.BEACH CHAIR — Conmed CorporationN/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.NA — STERIS CORPORATIONBAR, SPREADER, CERVICAL, 12" — MIZUHO ORTHOPEDIC SYSTEMS, INC.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Arthrex® — ARTHREX, INC.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Pivot Guardian — STRYKER CORPORATIONMORRISON MEDICAL — MORRISON MEDICAL, LTDN/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.Active Heel Traction Boot — Smith & Nephew, Inc.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.N/A — ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-03-11 | Baxter Healthcare Corporation | Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled inco |
| 2017-01-03 | Allen Medical Systems, Inc. | During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causin |
| 2016-11-23 | Allen Medical Systems, Inc. | During use, the unit could separate un-expectantly. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing m |
| 2014-12-29 | Dick's Sporting Goods | Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Table is a fitness product, not a medical device. DSG removed medic |
| 2014-01-29 | Implantech Associates Inc | Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robus |
| 2013-05-20 | Steris Corporation | A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliabi |
| 2013-02-28 | Allen Medical Systems, Inc. | Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall. |
| 2013-02-14 | Zimmer, Inc. | The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube. |
| 2009-07-31 | Linvatec Corp. dba ConMed Linvatec | ConMed has determined there is a possibility that the device may not fully retract once it is deployed. |
| 2009-07-27 | Stryker Endoscopy | Latex-- Certain lots of Product contain undeclared latex. |
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