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Cervico2000
MEDITRAC LTD. · Model CERV8 · UDI-DI 07290015711203
HST
Prescription
10
510(k) clearances
520
Adverse events (3 deaths)
11
Recalls
204
Facilities
Description
The Cervico 2000 provides safe, simple, compact, and effective treatment of cervical spine disorders, and brings to both the patient and physician a means of powerful, dynamic traction with simultaneous, three-dimensional action without the need for traction beds or restrictive braces. The Cervico 2000 allows the patient maximum mobility with minimal restrictions or discomfort during treatment. The Cervico 2000 facilitates the treatment of the patient by the health service professional while also allowing chronic sufferers to administer self-treatment under qualified medical supervision.
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.