Neuropro Spinal Jaxx Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 recall — FDA Z-1350-2018
The implant size is incorrectly etched on the implant. The size listed on the box is correct.
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The implant size is incorrectly etched on the implant. The size listed on the box is correct.
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
A component used within the braking system may break resulting in one or more brake pedals on the bed staying in brake or not being engaged which could result in unwanted bed movement and…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200…
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic…
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
The infusion sets were manufactured with an incorrect spin collar.
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical use. In the event of…
After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
The infusion sets were manufactured with an incorrect spin collar.
The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct…
Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot…
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by…
VITROS TSH reagent lots have been found to generate higher than expected Calibrator level 2 signals on some customer systems. These Calibrator Level 2 responses cause a higher than expected…
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control…
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