BIOSURE 72204411Recalls & reported problems
Smith & Nephew, Inc. · BIOSURE REGENSORB INTERFERENCE SCREW 11 MM X 25 MM · 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 00885554036879), received between Mar 7, 2024 and May 29, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K142948); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER AN ACL SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2025 DUE TO ANTERIOR KNEE PAIN AND SWELLING OVER THE TIBIAL TUNNEL LOCATION, DURING WHICH THE BIOSURE REGENESORB SCREW WAS REMOVED. CULTURES WERE TAKEN AND ARE PENDING. THE SURGEON SUGGESTED A FOREIGN BODY REACTION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN, AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 22107646 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW COULD NOT BE INSERTED AS THE THREADS OF THE SCREW BROKE WHILE INSERTED IN THE TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18856991 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142948. 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.
Other Fastener, fixation, biodegradable, soft tissue devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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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