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Extension rail
Reison Medical AB · Model 10-359-US · UDI-DI 07350111831783
10
510(k) clearances
1,802
Adverse events (2 deaths)
37
Recalls
159
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-14 | Baxter Healthcare Corporation | Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the |
| 2017-03-28 | Mizuho OSI | Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to contact the underlying |
| 2015-08-17 | Maquet Cardiovascular Us Sales, Llc | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) fo |
| 2015-08-17 | Maquet Cardiovascular Us Sales, Llc | Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) fo |
| 2014-12-19 | Integra LifeSciences Corporation | Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use. |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit |
| 2014-10-08 | Customed, Inc | Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage condit |
| 2014-10-08 | Customed, Inc | Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont |
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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.