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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
2014-10-16Z-0418-2015Class IITerminatedThe box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.Distribution: Nationwide Distribution to MN only1clearance family
2012-03-23Z-1543-2012TerminatedMarch 23, 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.—clearance family
2012-03-23Z-1544-2012TerminatedMarch 23, 2012 a field representative reported patient specific --0242 L tibia guide case packaging contained a different patient specific ..-0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.—clearance family
Regulatory clearances
  • 510(k)K140027Substantially equivalent (SESE) · 2014-05-22clearance family
  • 510(k)K133162Substantially equivalent (SESE) · 2014-02-25clearance family
  • 510(k)K121640Substantially equivalent (SESE) · 2012-12-05clearance family
  • 510(k)K112301Substantially equivalent (SESE) · 2012-01-06clearance family
  • 510(k)K111492Substantially equivalent (SESE) · 2011-10-13clearance family

Predicate lineage

Cited as predicate by: K102795, K103136, K111492, K112301

Cited as predicate by: K113829, K180220, K232561

Cited as predicate by: K172650

Cited as predicate by: K140027

K121640

Cited as predicate by: K133162, K140027

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

None in the loaded window.

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