SURFIXRecalls & reported problems across all models
Newdeal · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one SURFIX model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 5 models of SURFIX by Newdeal in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between Jun 4, 2022 and May 12, 2023 — classified as 2 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Fracture” (5 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
SURFIX 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.
- Jan 4, 2022Open, Classified
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Z-0548-2022 · Root cause: Process control · Recall details · FDA record ↗
Most reported SURFIX problems
Device problems
- Fracture5
- Break3
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Failure of Implant2
- Loss of Range of Motion2
- Pain2
- Insufficient Information1
SURFIX models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SURFIX® 219135NDSCREWDRIVER1 recall0 reports
- SURFIX® 219127NDSCREWDRIVER5 reports
- SURFIX CC040NDPLATE, FIXATION, BONE1 report
- SURFIX CC045NDPLATE, FIXATION, BONE1 report
- SURFIX® 219227NDSCREWDRIVER1 report
Recent SURFIX adverse event reports
The 8 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING REMOVAL SURGERY OF A HALLU-LOCK PLATE, A SCREWDRIVER TORX T7 BROKE OFF. NO PIECE FELL INTO THE PATIENT. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. NO OTHER INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924656 ↗InjuryDec 6, 2022Fracture; Fracture
IT WAS REPORTED THAT THREE (3) MONTHS AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE HEADS OF ONE (1) CORTICAL SCREW LOCK SCREW (D4.5-L45) INSERTED DISTAL TO THE OSTEOTOMY BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE SCREW: THE INTRAOSSEOUS PART OF THE SCREW WAS NOT REMOVED TO PREVENT FLOOR DAMAGE. DRILLING FOR THE NEW SCREW WAS DONE BICORTICALLY IN A SOMEWHAT MORE HORIZONTAL ALIGNMENT. THE PLATE WAS RETAINED.
Patient problems: Failure of Implant; Loss of Range of Motion; Pain
MAUDE report 15923890 ↗InjuryDec 1, 2022Fracture; Fracture
IT WAS REPORTED THAT, THREE (3) MONTHS AFTER AN INTERNAL FIXATION SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE HEAD OF A CORTICAL SCREW LOCK SCREW D4.5-L40 BROKE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXPLANT THE SCREW: THE INTRAOSSEOUS PART OF THE SCREW WAS NOT REMOVED TO PREVENT FLOOR DAMAGE. DRILLING FOR THE NEW SCREW WAS DONE BICORTICALLY IN A SOMEWHAT MORE HORIZONTAL ALIGNMENT. THE PLATE WAS RETAINED.
Patient problems: Failure of Implant; Loss of Range of Motion; Pain
MAUDE report 15901066 ↗MalfunctionJul 25, 2022Fracture; Fracture
IT WAS REPORTED THAT THE HEAD OF AN SCREWDRIVER TORX T7 WAS MISSING. THE INSTRUMENT CANNOT BE USED ANYMORE BECAUSE IT DOES NOT FIT SECURELY INTO THE HEAD OF THE SCREWS. AS THIS WAS NOTICED AFTER SURGERY, AND IT WAS CONFIRMED THAT THE BREAKAGE DID NOT OCCUR WHILE IN USE, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15093863 ↗MalfunctionJun 7, 2022Break; Fracture; Break; Fracture
IT WAS REPORTED THAT IN SURGERY THE HALLULOCK SCREWDRIVER BROKE DURING REMOVAL OF HALLULOCK PLATE AND SCREWS. NO FURTHER INFORMATION WAS AVAILABLE. IT IS UNKNOWN THE STATUS OF THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14629189 ↗MalfunctionJun 7, 2022Break; Break
IT WAS REPORTED THAT IN SURGERY THE HALLULOCK SCREWDRIVER BROKE DURING REMOVAL OF HALLULOCK PLATE AND SCREWS. NO FURTHER INFORMATION WAS AVAILABLE. IT IS UNKNOWN THE STATUS OF THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14629152 ↗MalfunctionJun 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING THE SET UP FOR A MTP-1 ARTHRODESIS SURGERY, IT WAS NOTICED THAT A PART OF THE TIP OF A SCREWDRIVER TORX T7 WAS MISSING. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599416 ↗MalfunctionJun 4, 2022Break; Break
IT WAS REPORTED THAT, DURING STERILIZATION PROCESS AFTER SURGERY, IT WAS NOTICED THAT A PART OF THE TIP OF THE SCREWDRIVER TORX T7 HAD BROKE. PROCEDURE BEEN COMPLETED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14599415 ↗
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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