BIOSURE 72201788Recalls & reported problems
Smith & Nephew, Inc. · 11 MM X 25 MM BIOSURE HA · Class 2 · Implant
All models of BIOSURE (68)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010611840), received between Jul 30, 2019 and Feb 24, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K080358); 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
- Device Dislodged or Dislocated1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BIOSURE SCREW DID NOT LOCK. THE SURGERY WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16436177 ↗MalfunctionJul 30, 2019Material Separation; Material Separation
IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW BROKE WHEN BEING IMPLANTED. AFTER REMOVAL, IT WAS REPLACED WITH A BACK UP DEVICE BUT IT IS UNKNOWN WHETHER ANOTHER BONE HOLE HAD TO BE DRILLED. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8842516 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K080358. One submission often covers many models, so check the product and lot details in each record.
- Z-0957-2026 · Nov 24, 2025 · Open, ClassifiedBIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Z-1225-2012 · Feb 6, 2012 · TerminatedSmith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- 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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