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MID CENTRAL MEDICAL CORP. · Model MCM158 · UDI-DI 10810030860324

FWZ

510(k) clearances

1,818

Adverse events (2 deaths)

Recalls

159

Facilities

Description

Pediatric single Loop Leg Prep is made from 3/8” 304 grade Stainless Steel and a soft molded pad. Used for prepping of the leg of children for surgery. Attaches to the side rail of operating table with clamp such as clark socket(sold separately) and any other clamp that accepts a 3/8" round rod. Depending on the clamp, this leg prepper can be adjusted in many different ways. Includes 1 soft molded pad. Replacements MCM156 (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	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	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

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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.