Orthofix TrueLok Hexapod System (TL-HEX) V2.0 1 (REF 50-10300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 18054242510666), received between May 20, 2021 and May 25, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K170650); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION PROVIDED BY LOCAL DISTRIBUTOR INDICATES: PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM) AND 50-10400 ((LONG STRUT TL-HEX - 158MM-318MM) BATCH NUMBER: B1452665 (CODE 50-10300) AND B1405090 (CODE 50-10400) AND B1406264 (CODE 50-10400) QUANTITY: 3 (MFR REPORTS 9680825-2021-00045 AND 9680825-2021-00046). PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. EVENT DESCRIPTION: "THROUGHOUT THE COURSE OF THE HEX PROGRAMME, 3 X MOUNTING CAPS DISLODGED RESULTING IN THE MOUNTING STUDS LOSING LOCKING ABILITY BETWEEN THE RING AND THE HEX STRUTS. FRAME INSTABILITY HAS EXPERIENCED. ". THE COMPLAINT REPORT FORM ALSO INDICATED: THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. AN ADDITIONAL SURGERY WAS NOT REQUIRED. A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS NOT REQUIRED. COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. PATIENT CURRENT HEALTH CONDITION: FRACTURE REDUCED AND ALIGNMENT ACQUIRED. MANUFA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11874908 ↗
• InjuryMay 20, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM ) - BATCH NUMBER: B1445646 - QUANTITY: (B)(4) (MFR REPORTS 9680825-2021-00041 AND 9680825-2021-00042 AND 9680825-2021-00043) - SURGERY DESCRIPTION: FRACTURE TREATMENT - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: "PRODUCT FAILED DURING CORRECTION OF HEX RING PROGRAM. 3 STRUTS FAILED ON RING". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION) - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED - COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN FURTHER INFORMATION RECEIVED ON MAY 24, 2021 FROM THE LOCAL DISTRIBUTOR: - DATE OF INITIAL SURGERY : (B)(6) 2020 - DATE OF THE DEVICE'S FAILURE: DURING (B)(6) 2021 TO (B)(6) 2021 - ANATOMICAL SITE: ANKLE - PATIENT INFORMATION (AGE,

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11853739 ↗
• InjuryMay 20, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: (B)(4) (MEDIUM STRUT TL-HEX - 114MM-184MM). - BATCH NUMBER: B1445646. - QUANTITY: (B)(4) (MFR REPORTS 9680825-2021-00041 AND 9680825-2021-00042 AND 9680825-2021-00043). - SURGERY DESCRIPTION: FRACTURE TREATMENT. - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE. - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM. - EVENT DESCRIPTION: "PRODUCT FAILED DURING CORRECTION OF HEX RING PROGRAM. 3 STRUTS FAILED ON RING". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION). - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE. - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE. - AN ADDITIONAL SURGERY WAS NOT REQUIRED. - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED. - COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE. - PRODUCT IS AVAILABLE FOR RETURN. FURTHER INFORMATION RECEIVED ON MAY 24, 2021 FROM THE LOCAL DISTRIBUTOR: - DATE OF INITIAL SURGERY : (B)(6) 2020. - DATE OF THE DEVICE'S FAILURE: DURING (B)(6) 2021 TO (B)(6) 2021. - ANATOMICAL SITE: ANKLE. - PATIENT INFOR

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11853738 ↗
• InjuryMay 20, 2021Mechanical Problem; Mechanical Problem

  THE INFORMATION INITIALLY PROVIDED BY LOCAL DISTRIBUTOR INDICATES: - PRODUCT CODE: 50-10300 (MEDIUM STRUT TL-HEX - 114MM-184MM ) - BATCH NUMBER: B1445646 - QUANTITY: (B)(4) (MFR REPORTS 9680825-2021-00041 AND 9680825-2021-00042 AND 9680825-2021-00043) - SURGERY DESCRIPTION: FRACTURE TREATMENT - PROBLEM OBSERVED DURING: INTO TREATMENT/POST-OPERATIVE - TYPE OF PROBLEM: DEVICE FUNCTIONAL PROBLEM - EVENT DESCRIPTION: "PRODUCT FAILED DURING CORRECTION OF HEX RING PROGRAM. 3 STRUTS FAILED ON RING". THE COMPLAINT REPORT FORM ALSO INDICATED: - THE DEVICE FAILURE HAD ADVERSE EFFECTS ON PATIENT (LOSS OF ACHIEVED CORRECTION) - THE INITIAL SURGERY WAS COMPLETED WITH THE DEVICE - THE EVENT DID NOT LEAD TO A DELAY IN THE DURATION OF THE SURGICAL PROCEDURE - AN ADDITIONAL SURGERY WAS NOT REQUIRED - A MEDICAL INTERVENTION (OUTPATIENT CLINIC) WAS REQUIRED - COPIES OF THE OPERATIVE REPORTS AND COPIES OF THE X-RAY IMAGES ARE NOT AVAILABLE - PRODUCT IS AVAILABLE FOR RETURN FURTHER INFORMATION RECEIVED ON MAY 24, 2021 FROM THE LOCAL DISTRIBUTOR: - DATE OF INITIAL SURGERY : (B)(6) 2020 - DATE OF THE DEVICE'S FAILURE: DURING (B)(6) 2021 TO (B)(6)2021 - ANATOMICAL SITE: ANKLE - PATIENT INFORMATION (AGE, S

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11853737 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170650. One submission often covers many models, so check the product and lot details in each record.

• Z-2063-2018 · Jan 30, 2018 · Terminated
  TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of r