TSI · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2020-05-15	Z-2527-2020	Class II	Terminated	Lack of pouch seal. Product is labelled as sterile.Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.	1965 screws (packaged into 393 boxes) - [5 screw per box]	code info di

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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