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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
InitiatedRecall #ClassStatusReasonQuantityLink basis
2019-11-04Z-1635-2020Class IITerminatedThe firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.Distribution: Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.117clearance family
Regulatory clearances
  • 510(k)K121008Substantially equivalent (SESE) · 2012-06-04clearance family

Predicate lineage

Cited as predicate by: K122959, K161449, K181898, K182684

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2019-12-11VAIVoluntary action indicatedTrilliant Surgical, LLC5
2019-12-11VAIVoluntary action indicatedTrilliant Surgical, LLC5
2018-05-02VAIVoluntary action indicatedTrilliant Surgical, LLC10
2018-05-02VAIVoluntary action indicatedTrilliant Surgical, LLC10
2016-06-27OAIOfficial action indicatedTrilliant Surgical, LLC9
2016-06-27OAIOfficial action indicatedTrilliant Surgical, LLC9
2015-02-12OAIOfficial action indicatedTrilliant Surgical, LLC5
2015-02-12OAIOfficial action indicatedTrilliant Surgical, LLC5
2011-09-09VAIVoluntary action indicatedTrilliant Surgical, LLC3
2011-09-09VAIVoluntary action indicatedTrilliant Surgical, LLC3
2010-05-03WLWarning LetterTrilliant Surgical, LLC—
2010-05-03WLWarning LetterTrilliant Surgical, LLC—
2010-01-20OAIOfficial action indicatedTrilliant Surgical, LLC4
2010-01-20OAIOfficial action indicatedTrilliant Surgical, LLC4
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