Home › Smith & Nephew, Inc. › Active Heel Traction Boot
Active Heel Traction Boot
Smith & Nephew, Inc. · Model 72203272 · UDI-DI 03596010656346
HST
Prescription
10
510(k) clearances
519
Adverse events (3 deaths)
11
Recalls
202
Facilities
Description
KIT AHTB RETRFIT HARDWARE UNIV HIP DISTR
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 incorrectly. The locking |
| 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 causing a delay in surgery |
| 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 moderate injury to th |
| 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 medical claims from produ |
| 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 robustness of the Velcro |
| 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 reliability testing and was |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.