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Torx 2030-6545-1Recalls & reported problems

Howmedica Osteonics Corp. · Cancellous Bone Screw · Class 2 · Implant

All models of Torx (7)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327037036), received between Feb 14, 2019 and Feb 14, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

32 other recalls cover devices cleared under the same FDA submission (K873251, K894124); 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

Device problems

  • Break1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 14, 2019Break; Break

    IT WAS REPORTED THAT WHILE THE SURGEON WAS ATTEMPTING TO TIGHTEN THE SCREW, THE SCREW HEAD SHEARED OFF THE SHAFT OF THE SCREW. IT WAS REPORTED THAT A SURGICAL DELAY OF 1 HOUR WAS NOTED WHILE THE SURGEON ATTEMPTED TO REMOVE THE SHAFT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8338963 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K873251, K894124. One submission often covers many models, so check the product and lot details in each record.

  • Z-0483-2014 · Oct 1, 2013 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5
  • Z-0387-2013 · Aug 17, 2012 · Terminated
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell i
  • Z-0388-2013 · Aug 17, 2012 · Terminated
    Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell i
  • Z-2120-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 30 mm; Sterile; Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
  • Z-2131-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 50 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
  • Z-2132-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are optional fixt
  • Z-2135-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 20 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
  • Z-2118-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 20 mm; Sterile Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are opt
  • Z-2127-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
  • Z-2142-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 55 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
  • Z-2141-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 50 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430
  • Z-2121-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 40 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
  • Z-2117-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 6.5 mm; Lnth: 16 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
  • Z-2128-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Cancellous Bone Screw; Dia 5.5 mm; Lnth: 30 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The bone screws are op
  • Z-2136-2009 · Jun 26, 2009 · Terminated
    Stryker Orthopaedics Restoration Gap Plate Screw; Dia. 6.5 mm, Lnth 25 mm; Made in USA, Sterile; Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430

…and 17 more.

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Sources and updates

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