BIOSURERecalls & reported problems across all models
Smith & Nephew, Inc. · 68 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one BIOSURE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 982
- Deaths reported
- 0
- Injuries reported
- 339
- Recalls
- 1
We found 68 models of BIOSURE by Smith & Nephew, Inc. in the FDA's device registry (GUDID). Together they are named in 982 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2017 and Jun 22, 2026 — classified as 339 injuries, 643 malfunctions.
The most frequently reported specific device problem is “Break” (716 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
BIOSURE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 24, 2025Open, Classified
Removal of affected lot of screws due to labeling error.
Z-0957-2026 · Root cause: Packaging process control · names 2 of these models · Recall details · FDA record ↗
Most reported BIOSURE problems
Device problems
- Break716
- Material Separation88
- Fracture49
- Adverse Event Without Identified Device or Use Problem29
- Crack21
- Material Deformation20
- Device Dislodged or Dislocated19
- Insufficient Device Problem Information16
Patient problems
- No Clinical Signs, Symptoms or Conditions645
- No Known Impact Or Consequence To Patient174
- Foreign Body In Patient42
- Device Embedded In Tissue or Plaque32
- No Information21
- Pain13
- Perforation13
- Insufficient Information12
BIOSURE models
68 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BIOSURE 72201782Screw, fixation, bone95 reports
- BIOSURE 72201768Screw, fixation, bone1 recall31 reports
- BIOSURE 72201781Screw, fixation, bone74 reports
- BIOSURE 72204389Fastener, fixation, biodegradable, soft tissue1 recall17 reports
- BIOSURE 72201769Screw, fixation, bone63 reports
- BIOSURE 72201772Screw, fixation, bone52 reports
- BIOSURE 72201776Screw, fixation, bone43 reports
- BIOSURE 72204409Fastener, fixation, biodegradable, soft tissue39 reports
- BIOSURE 72204401Fastener, fixation, biodegradable, soft tissue34 reports
- BIOSURE 72204399Fastener, fixation, biodegradable, soft tissue33 reports
- BIOSURE 72204405Fastener, fixation, biodegradable, soft tissue32 reports
- BIOSURE 72201778Screw, fixation, bone30 reports
- BIOSURE 72204408Fastener, fixation, biodegradable, soft tissue29 reports
- BIOSURE 72204395Fastener, fixation, biodegradable, soft tissue27 reports
- BIOSURE 72202745FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE27 reports
- BIOSURE 72204404Fastener, fixation, biodegradable, soft tissue26 reports
- BIOSURE 72204391Fastener, fixation, biodegradable, soft tissue22 reports
- BIOSURE 72201774Screw, fixation, bone21 reports
- BIOSURE 72204390Fastener, fixation, biodegradable, soft tissue19 reports
- BIOSURE 7211138ORTHOPEDIC MANUAL SURGICAL INSTRUMENT17 reports
- BIOSURE 72204394Fastener, fixation, biodegradable, soft tissue16 reports
- BIOSURE 72201785Screw, fixation, bone16 reports
- BIOSURE 72204392Fastener, fixation, biodegradable, soft tissue14 reports
- BIOSURE 72202263FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE14 reports
- BIOSURE 72204397Fastener, fixation, biodegradable, soft tissue12 reports
- BIOSURE 72201786Screw, fixation, bone12 reports
- BIOSURE 72204412Fastener, fixation, biodegradable, soft tissue11 reports
- BIOSURE 72202273FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE11 reports
- BIOSURE 72201887DRIVER, PROSTHESIS10 reports
- BIOSURE 72201775Screw, fixation, bone9 reports
- BIOSURE 72202267FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE9 reports
- BIOSURE 72204398Fastener, fixation, biodegradable, soft tissue8 reports
- BIOSURE 72201888ACCESSORIES,ARTHROSCOPIC8 reports
- BIOSURE 72202260FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE8 reports
- BIOSURE 72201771Screw, fixation, bone7 reports
- BIOSURE 72202272FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE7 reports
- BIOSURE 72202269FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE7 reports
- BIOSURE 72202746Screw, fixation, bone7 reports
- BIOSURE 72201201ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- BIOSURE 72204410Fastener, fixation, biodegradable, soft tissue5 reports
- BIOSURE 72201789Screw, fixation, bone5 reports
- BIOSURE 72204402Fastener, fixation, biodegradable, soft tissue3 reports
- BIOSURE 72204403Fastener, fixation, biodegradable, soft tissue3 reports
- BIOSURE 72204406Fastener, fixation, biodegradable, soft tissue3 reports
- BIOSURE 72202276FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- BIOSURE 72202277FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- BIOSURE 72203252ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- BIOSURE 72203253ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- BIOSURE 72204396Fastener, fixation, biodegradable, soft tissue2 reports
- BIOSURE 72204400Fastener, fixation, biodegradable, soft tissue2 reports
- BIOSURE 72204411Fastener, fixation, biodegradable, soft tissue2 reports
- BIOSURE 7211137ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- BIOSURE 72201780Screw, fixation, bone2 reports
- BIOSURE 72201783Screw, fixation, bone2 reports
- BIOSURE 72201787Screw, fixation, bone2 reports
- BIOSURE 72201788Screw, fixation, bone2 reports
- BIOSURE 72202262FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
- BIOSURE 72202752ACCESSORIES,ARTHROSCOPIC2 reports
- BIOSURE 72202475ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- BIOSURE 72204413Fastener, fixation, biodegradable, soft tissue1 report
- BIOSURE 72202757FACCESSORIES,ARTHROSCOPIC1 report
- BIOSURE 72201779Screw, fixation, bone1 report
- BIOSURE 72202266FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- BIOSURE 72202270FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- BIOSURE 72202279FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- BIOSURE 72202280FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- BIOSURE 72202744FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 report
- BIOSURE 72202754ACCESSORIES,ARTHROSCOPIC1 report
Recent BIOSURE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT, DURING AN ACL SURGERY, WHILE INSERTING ONE (1) 7 MM X 20 MM BIOSOURCE REGENESORB SCREW INTO THE TIBIAL TUNNEL, THE SCREW THREADS WERE DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25588123 ↗MalfunctionJun 20, 2026Fracture
IT WAS REPORTED THAT DURING A MEDIAL COLLATERAL LIGAMENT (MCL) RECONSTRUCTION SURGERY, THE HEAD OF A BIOSURE HA 9 MM X 30 MM ANCHOR FRACTURED. THE PROCEDURE WAS RESUMED, AFTER LESS THAN OR EQUAL TO 30MINS, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25570276 ↗MalfunctionJun 15, 2026Fracture
IT WAS REPORTED THAT, DURING A TIBIAL FIXATION, THE ANCHOR OF ONE (1) BIOSURE HA WAS FRACTURED UPON SCREWING IN. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25503612 ↗MalfunctionJun 8, 2026Break
IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION, ONE (1) BIOSURE ANCHOR BROKE. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425966 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE BIOSURE SCREW WAS SCREWED IN ALONG THE GUIDE. THE TAIL OF THE SCREW WAS FRACTURED HALFWAY THROUGH. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356544 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT, DURING A SURGERY, THE GUIDE WIRE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356508 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE DURING IMPLANTATION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352919 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING AN ACL ARTHROSCOPY, UPON INSERTION THE BIOSURE SCREW BROKE IN THE TIBIAL CANAL. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING KELLY FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. PATIENT WAS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344217 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING AN ACL REPAIR, A BIOSURE SCREW BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344143 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE DURING IMPLANTATION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344061 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE DURING IMPLANTATION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25344019 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE SYNC 7-8MM BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION AND TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342976 ↗MalfunctionMay 31, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE SYNC 9-10MM BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342877 ↗MalfunctionMay 29, 2026Break
IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE DURING IMPLANTATION. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP. BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, THERE WAS NO VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333475 ↗MalfunctionMay 27, 2026Fracture
IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A NITINOL GUIDE WIRE WAS INSERTED, THE HOLE WAS PREPARED WITH A 9.0 DRILL BIT AND TAPPED WITH AN 8 MM TAP, AND A BIOSURE SCREW WAS INSERTED; UPON TIGHTENING, THE SCREW FRACTURED INTO MULTIPLE PIECES. THE BROKEN PIECES WERE REMOVED USING KELLY TWEEZERS. PART OF THE SCREW REMAINED IN THE BONE HOLE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A COMPETITOR DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.
Patient problems: Device Embedded In Tissue or Plaque; Perforation
MAUDE report 25295992 ↗
Other Smith & Nephew, Inc. products
- FAST-FIX18 models · 9,554 reports
- JOURNEY566 models · 6,250 reports · 4 recalls
- GENESIS II462 models · 4,599 reports · 2 recalls
- DYONICS, POWERMAX, ELITE2 models · 4,308 reports
- TRIGEN381 models · 3,599 reports · 5 recalls
- LEGION446 models · 2,039 reports · 4 recalls
- REAL INTELLIGENCE32 models · 2,017 reports · 3 recalls
- Coblation62 models · 2,126 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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