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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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 · TerminatedStryker 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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- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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