NA 201.774Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982142801), received between Dec 11, 2017 and Nov 18, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K002271, K063049, K102694, K112583); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827252 ↗
• MalfunctionOct 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SOME OF THE 2.4MM CORTEX SCREWS WERE NOT FITTING THROUGH THE PLATE GUIDES FOR THE TWO COLUMN VARIABLE ANGLE DISTAL RADIUS PLATES. THE SET WAS OPENED AND TESTED THE THREE (3) 2.4MM CORTEX SCREWS 20MM, TWO (2) 2.4MM CORTEX 22MM, AND ONE (1) 2.4MM CORTEX 24MM. THE 2.4MM CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK FOR TWO-COLUMN PLATE 6 HOLE HEAD, GUIDE BLOCK FOR TWO-COLUMN PLATE 7 HOLE HEAD, NOR THE GUIDE BLOCK FOR TWO-COLUMN PLATE NARROW 6 HOLE. THE REST OF THE 2.4MM CORTEX SCREWS DID. THE ISSUE WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS 6 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244339 ↗
• MalfunctionMay 3, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCRUB TRIED ON THE BACK TABLE AND ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 12MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, TWO (2) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS  24MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THESE INCIDENTS WILL BE CAPTURED UNDER THIS (B)(4) FOR (10 DEVICES) AND LINKED (B)(4) FOR (6 DEVICES). THIS REPORT IF FOR SIX (6) DEVICES. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8579786 ↗
• MalfunctionMay 3, 2019Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SCRUB TRIED ON THE BACK TABLE AND ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 12MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, THREE(3) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 18MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 22MM, TWO (2) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS  24MM, ONE (1) CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES SIXTEEN (16) DEVICES. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THESE INCIDENTS WILL BE CAPTURED UNDER THIS (B)(4) FOR (10 DEVICES) AND LINKED (B)(4) FOR (6 DEVICES). THIS REPORT IF FOR SIX (6) DEVICES. THIS REPORT IS 3 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8579775 ↗
• MalfunctionMay 3, 2019Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON (B)(6) 2019, POST-OPERATIVE, THE SCRUB NOTED FOLLOWING ON THE BACK TABLE: ONE (1) CORTEX SCREW 18MM BECAME INCARCERATED IN THE GUIDE BLOCK. ADDITIONALLY, THREE (3) CORTEX SCREWS 12MM, THREE (3) CORTEX SCREWS 14MM, ONE (1) CORTEX SCREW 16MM THREE (3) CORTEX SCREWS 18MM, ONE (1) CORTEX SCREW 22MM, TWO (2) CORTEX SCREW 24MM, AND ONE (1) CORTEX SCREW 28MM WOULD NOT FIT THROUGH THE GUIDE BLOCK. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES 16 DEVICES DUE TO THE SYSTEM LIMITATION, THIS INCIDENT WILL BE CAPTURED UNDER THIS (B)(4) (10 DEVICES) AND LINKED (B)(4) (6 DEVICES). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW 12MM. THIS IS REPORT 1 OF 10 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8578542 ↗
• MalfunctionDec 11, 2017Break; Break

  IT WAS REPORTED THAT A 2.4 MM LOCKING COMPRESSION PLATE (LCP) AND FOUR (4) 2.4 MM CORTEX SCREWS WERE USED FOR PROVISIONAL FIXATION TO HOLD REDUCTION OF FRAGMENTS DURING AN ORIF(OPEN REDUCTION INTERNAL FIXATION) OF A HUMERUS. REDUCTION WAS ACHIEVED AND SURGEON BEGAN TO REMOVE THE 2.4 MM LCP PLATE AND 2.4 MM CORTEX SCREWS WHEN ONE OF THE HEAD OF THE 2.4 MM CORTEX SCREW BROKE AND THE SHAFT OF THE SCREW WAS RETAINED IN THE PATIENT. THE SURGEON DID NOT ATTEMPT REMOVAL OF THE SCREW SHAFT. THE THREE (3) REMAINING 2.4 MM CORTEX SCREWS WERE EASILY REMOVED. A 3.5 MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATE WAS APPLIED ALONG WITH A COMBINATION OF 3.5 MM LOCKING SCREWS AND 3.5 MM CORTICAL SCREWS FOR SUCCESSFUL COMPLETION OF THE PROCEDURE. THERE WAS NO SURGICAL DELAY, ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN. THE PATIENT WAS REPORTED TO BE STABLE. THE BROKEN SCREW HEAD WAS DISCARDED BY THE HOSPITAL ALONG WITH THE 2.4 MM LCP PLATE AND THE REMAINING (3) 2.4 MM CORTEX SCREWS. CONCOMITANT DEVICES REPORTED: 2.4 MM LCP PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1), SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY OF 1). THIS REPORT IS FOR ONE (1) 2.4 MM CORTEX SCREW SLF-TPNG WITH T8 STARDR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7106044 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002271, K063049, K102694, K112583. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor