NA 71930020Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00885556049709), received between May 29, 2020 and Jan 28, 2026 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) CORKSCREW FEM HEAD REMOVER IS BROKE. PATIENT WAS NOT AFFECTED. THERE WAS NO SURGICAL DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202643 ↗
• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A THR SURGERY, IT WAS NOTICED THAT THE TIP OF TWO (2) CORKSCREW FEM HEAD REMOVER BROKE OFF MAKING THEM NOT USABLE. SINCE INCIDENT OCCURRED AFTER PROCEDURE; PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290840 ↗
• MalfunctionOct 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY ONE (1) CORKSCREW FEM HEAD REMOVER BROKE OFF DURING BORING. ALL PARTS WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23262605 ↗
• MalfunctionJun 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE SHAFT OF ONE ONE (1) CORKSCREW FEM HEAD REMOVER BROKE INTRA-OP. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292199 ↗
• MalfunctionJun 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THE REMOVAL OF A DIFFICULT FEMORAL HEAD IN A THR SURGERY, ONE (1) CORKSCREW FEM HEAD REMOVER SNAPPED OFF IN THE HUDSON CHUCK ORTHOPEDIC DRILL THAT WAS BEING USED. THE PROCEDURE WAS RESUMED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520656 ↗
• MalfunctionApr 29, 2024Material Fragmentation; Deformation Due to Compressive Stress; Material Deformation; Material Fragmentation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT THE END OF THE CONNECTION TO POWER OF A CORKSCREW FEM HEAD REMOVER WAS DAMAGED AND CONTINUED TO GET STUCK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209021 ↗
• MalfunctionNov 29, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ANTERIOR HIP PROCEDURE, ONE (1) CORKSCREW FEM HEAD REMOVER WAS BENT AND OFF BALANCE OR RECEIVING END IS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229830 ↗
• MalfunctionFeb 16, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR A SURGERY, THE TIP OF A CORKSCREW FEM HEAD REMOVER BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546319 ↗
• InjuryJan 27, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT, DURING A THR SURGERY, A CORKSCREW FEM HEAD REMOVER DETACHED FROM T-HANDLE. INCIDENT OCCURRED WITH INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365043 ↗
• MalfunctionDec 28, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR, THE CORKSCREW FEM HEAD REMOVER BROKE OUTSIDE PATIENT. NO PIECES FELL INTO PATIENT. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED. HOSPITAL DISCARDED INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094908 ↗
• MalfunctionOct 12, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A CORKSCREW FEM HEAD REMOVER BROKE. IT IS UNKNOWN IF THE DEVICE BROKE OUTSIDE OR INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY, IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616290 ↗
• MalfunctionOct 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A CORKSCREW FEM HEAD REMOVER BROKE. IT IS UNKNOWN HOW THIS PROCEDURE WAS FINISHED AND IF THERE WERE ANY SURGICAL DELAY. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12595110 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED THAT, A CORKSCREW FEM HEAD REMOVER IS BROKEN AND WILL NOT CHUCK UP TO DRILL. AS THIS WAS NOTICED DURING INSPECTION ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864542 ↗
• MalfunctionMay 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A CORKSCREW FEM HEAD REMOVER BROKE. THE INSTRUMENT WAS OUTSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773582 ↗
• MalfunctionApr 21, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE END OF THE CORKSCREW FEMORAL HEAD REMOVER THAT GOES ON TO THE POWER DRILL IS WORN. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704469 ↗
• MalfunctionApr 18, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING INSTRUMENT CLEANING/INSPECTION PROCESS, THE TIP OF THE CORKSCREW FEM HEAD REMOVER WAS FOUND TO BE SEVERELY DULLED AND CHIPPED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683586 ↗
• MalfunctionApr 18, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING INSTRUMENT CLEANING/INSPECTION PROCESS, THE TIP OF THE CORKSCREW FEM HEAD REMOVER WAS FOUND TO BE SEVERELY CHIPPED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683582 ↗
• MalfunctionApr 11, 2021Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE CORKSCREW IS WORN. NO CASE OR PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646857 ↗
• MalfunctionMar 10, 2021Loose or Intermittent Connection; Dent in Material; Loose or Intermittent Connection; Dent in Material

  IT WAS REPORTED THAT, DURING INSPECTION FOR A TKA PROCEDURE, THE CORKSCREW FEM HEAD REMOVER WAS FOUND BROKEN AND DENTED ON ONE OF THE ENDS. THERE WAS NO DELAY OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449818 ↗
• MalfunctionFeb 15, 2021Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. UNKNOWN WHEN THE INCIDENT OCCURRED, IF OCCURRED A SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326719 ↗
• MalfunctionJan 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE CORKSCREW WAS STRIPPED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11158043 ↗
• MalfunctionJan 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, THE CORKSCREW WAS STRIPPED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11157857 ↗
• MalfunctionDec 21, 2020Crack; Crack

  IT WAS REPORTED THAT THE DEVICE WAS FOUND CRACKED. THIS WAS FOUND DURING SET UP / INSPECTION. NO SURGERY OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11049731 ↗
• MalfunctionDec 4, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED DURING THE PROCEDURE THAT THE TIP OF THE DEVICE DOESN'T SHARP, WHICH MADE IT DIFFICULT TO INSERT THE BONE HEAD. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. IT IS UNKNOWN HOW WAS THE SURGERY FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945663 ↗
• MalfunctionNov 26, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE TOP OF THE CORKSCREW IS WORN AND NEEDS TO BE REPLACED. NO CASE OR PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910945 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a