NA 212.122Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982151964), received between Apr 8, 2019 and Apr 8, 2019 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K000684); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF PROXIMAL HUMERUS. THE ONE (1) LOCKING COMPRESSION PLATE PROXIMAL HUMERUS PLATE-STANDARD 3H HEAD SHAFT, ONE (1) CORTEX SCREW SELF-TAPPING 34MM, ONE (1) CORTEX SCREW SELF-TAPPING 30MM, TWO (2) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 52MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 48MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 38MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 50MM, ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE RECESS 46MM AND ONE (1) LOCKING SCREW SELF-TAPING WITH STARDRIVE (TM) RECESS 32MM WAS REMOVED DUE TO NONUNION OF THE RIGHT PROXIMAL HUMERUS FRACTURE OF THE PATIENT. HARDWARE WAS IMPLANTED ON (B)(6) 2017. ALL HARDWARE WAS REMOVED SUCCESSFULLY AND INTACT. NOTHING WAS BROKEN. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT REPORTS TOTAL 11 DEVICES. DUE TO SYSTEM LIMITATION TEN (10) DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4) AND REMAINING ONE (1) DEVICE IS

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8492893 ↗
• InjuryApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT PROXIMAL HUMERUS DUE TO NONUNION. THE FOLLOWING HARDWARE WAS REMOVED: ONE (1) LOCKING COMPRESSION PLATE (LCP) PROXIMAL HUMERUS PLATE-STANDARD 3H HEAD SHAFT. ONE (1) CORTEX SCREW SELF-TAPPING 34MM. ONE (1) CORTEX SCREW SELF-TAPPING 30MM. TWO (2) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 52MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 40MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 48MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 38MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 50MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 46MM. ONE (1) LOCKING SCREW SELF-TAPPING WITH STARDRIVE (TM) RECESS 32MM. HARDWARE WAS ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL HARDWARE WAS REMOVED SUCCESSFULLY AND INTACT. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.5MM LOCKING SCREW SELF-TAPPING WITH STARDRIVE RECESS 52MM. THIS IS REPORT 4 OF 10 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Impaired Healing; No Code Available

  MAUDE report 8491502 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,