NA 01-001-03-0001Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885862256607), received between Jul 12, 2021 and Jul 2, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

11 other recalls cover devices cleared under the same FDA submission (K032964, K051682, K103012, K121392, K173583); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT THE PLASTIC TIP ON THE FEMORAL BALL IMPACTOR BROKE INTO TWO PIECES UPON IMPACTION OF THE FINAL IMPLANT. REPORTED EVENT OCCURRED DURING SURGICAL USE. EVENT IS NOT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS. EVENT LED TO A MINIMAL SURGICAL DELAY/PROLONGATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS AVAILABLE FOR RETURN. PRODUCT RETURNING: RG647551.289GLEN, FEMORAL BALL IMPACTOR, 0100103001, 70713001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661914 ↗
• MalfunctionJul 2, 2024Break; Break

  THE BALL PUSHER PLASTIC CRACKED AND BROKE. THE EVENT OCCURRED DURING SURGICAL USE. REPORTED EVENT IS NOT ASSOCIATED WITH REVISION OF EXACTECH IMPLANTS. THE EVENT DID CAUSE A 5-15 MINUTE SURGICAL DELAY/PROLONGATION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE SURGICAL DELAY/PROLONGATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661765 ↗
• MalfunctionOct 2, 2023Break; Material Fragmentation; Break; Material Fragmentation

  AS REPORTED, THE REP WAS PUTTING TRAYS BACK TOGETHER IN SPD AND NOTICED THAT THE EDGE OF THE HEAD IMPACTOR WAS CHIPPED. THE REP IS NOT SURE WHEN THE IMPACTOR EDGE WAS DAMAGED. HIS GUESS IS DURING POST-OP CLEANING PROCESS. IT WAS NOT NOTICED IN CASES AND DID NOT AFFECT ANY PROCEDURES. BECAUSE TWO CASES WERE DONE THAT DAY, THE REP IS UNSURE WHICH CASE THE IMPACTOR WAS USED ON. THE PATIENTS WERE LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858150 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT THIS INSTRUMENT BROKE ON THE BACK TABLE. NO PARTS OR PIECES FELL INTO THE PATIENT. NO SURGICAL DELAY/PROLONGATION. NO PROBLEMS OCCURRED. NO PATIENT INFORMATION REPORTED. PHOTO ATTACHED. PRODUCT NOT RETURNING - PIECES WERE THROWN OUT BY HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641019 ↗
• MalfunctionJun 26, 2023Break; Fracture; Break; Fracture

  AS REPORTED, DURING A THA REVISION OF 71 Y/O MALE PATIENT FOR A HEAD LINER EXCHANGE CASE, THE SURGEON WHEN TO USE THE FEMORAL HEAD IMPACTOR TO IMPACT THE REAL FEMORAL HEAD IMPLANT ONTO THE NECK OF THE FEMORAL STEM. WHEN USING A STANDARD ORTHOPEDIC MALLET HE HIT THE HEAD IMPACTOR TOOL TWICE BEFORE IT CRACKED IN HALF AND BROKE. THE HEAD IMPACTOR BROKE IN HALF AND FELL INTO THE WOUND. THE SURGEON REMOVED ALL PIECES. SURGEON HAD TO USE DIFFERENT ITEM TO IMPACT THE HEAD. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. IMAGE RECEIVED. SALES REP WAS UNABLE TO OBTAIN X-RAYS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS THROWN AWAY ON ACCIDENT DURING CLEAN UP. CUSTOMER NEEDS ITEM REPLACED FOR CASES NEXT WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17202656 ↗
• MalfunctionJul 12, 2021Break; Break

  AS REPORTED, DURING IMPACTION, BLACK PLASTIC OF HEAD IMPACTOR BROKE INTO PIECES WHILE IMPACTING FINAL HEAD IMPLANT. SURGEON HAD TO OPEN ANOTHER TRAY FOR IMPACTOR. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NURSE THREW AWAY BROKEN PLASTIC HEAD IMPACTOR TIP. STILL HAVE HANDLE. THE DEVICE WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12150680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032964, K051682, K103012, K121392, K173583. One submission often covers many models, so check the product and lot details in each record.

• Z-1165-2025 · Dec 31, 2024 · Open, Classified
  AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-2
• Z-1166-2025 · Dec 31, 2024 · Open, Classified
  Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G2
• Z-0577-2024 · Nov 21, 2023 · Open, Classified
  AcuMatch Hip System, Catalog Number 142-32-27
• Z-1732-2022 · Aug 11, 2022 · Open, Classified
  GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL,
• Z-2123-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40
• Z-2118-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; and Novation GXL Liner, Neutral,
• Z-2129-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized, 40mm. Orthopedic hip implant
• Z-2133-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant,
• Z-2117-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral,
• Z-2119-2021 · Jun 29, 2021 · Open, Classified
  Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component
• Z-0572-2008 · Nov 1, 2007 · Terminated
  Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653