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MID CENTRAL MEDICAL CORP. · Model MCM150 · UDI-DI 10810030860270

FWZ

510(k) clearances

1,831

Adverse events (2 deaths)

Recalls

159

Facilities

Description

Candy Cane Stirrup (1 only) designed to hold patients lower limbs during lithotomy cases. Constructed from 304 stainless steel for durability and longevity. Integral clamp allows height adjustment for 23"–41". Large 8" arc allows for additional leg clearance. Mounts to OR table rail with clark socket (MCM160 sold separately). 1" wide cotton strap that conforms to 9" loops is included. 60 lb. capacity. Mounts with standard clark socket(sold separately).

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	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

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Data 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.