TC-PLUS 75006076Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996009231), received between Jan 8, 2020 and Jan 8, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K000666); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING KNEE REPLACEMENT SURGERY, THE INSERT OF 6/11 COULD NOT BE PLACED IN THE POSTERIOR SLOT OF TIBIAL BASEPLATE, RESULTING IN INSERT DAMAGE . FINALLY A INSERT OF 6/9 WAS USED TO COMPLETE THE SURGERY. NO EXTRA BONE CUTS WERE MADE TO PLACE 6/9 INSERT. DELAY GREATER THAN 30 MINUTES WAS RECORDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9567155 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000666. One submission often covers many models, so check the product and lot details in each record.

• Z-0018-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
• Z-0013-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456
• Z-0019-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
• Z-0017-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436
• Z-0014-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert 2; 15mm, Model 25309
• Z-0015-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 4; 11mm, Model 25427
• Z-0016-06 · Aug 3, 2005 · Terminated
  TC-PLUS Tibial Insert UC 4; 13mm, Model 25428
• Z-0126-06 · Feb 22, 2005 · Terminated
  TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
• Z-0017-04 · Apr 17, 2003 · Terminated
  TC-PLUS Solution Tibial Component-- Symmetric