NA 209-30-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885862056191), received between Jul 20, 2020 and Apr 12, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

5 other recalls cover devices cleared under the same FDA submission (K150890, K954208); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2021Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11654183 ↗
• MalfunctionApr 12, 2021Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11654176 ↗
• MalfunctionDec 21, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049979 ↗
• MalfunctionDec 21, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED, AND WILL NOT RETURN. THE DRIVER WILL BE RETURNING. NO PATIENT INFO. PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049884 ↗
• MalfunctionDec 21, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11049668 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297795 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC, WHILE LOCKING THE INSERT TO THE BASE PLATE, THE BALL TIP DRIVER BROKE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297640 ↗
• MalfunctionJul 20, 2020Break; Break

  DURING A REVISION FROM A PRIMARY TO A CC. IT HAS HAPPENED WHILE LOCKING THE INSERT TO THE BASE PLATE, RESULTING IN MAJOR DIFFICULTIES TO RETRIEVE THE BROKEN TIP LEFT IN THE SCREW HEAD. ALL PIECES WERE RETRIEVED, WITH LESS THAN 5 MIN DELAY TO SURGERY. THE TIP WAS DISCARDED AND WILL NOT RETURN, THE DRIVER WILL BE RETURNING. NO PATIENT INFO PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296710 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150890, K954208. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-0582-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-2704-2017 · Apr 7, 2017 · Terminated
  Exactech Optetrak Logic CC 15mm Tibial Augment Screws