Affixus Natural NailRecalls & reported problems across all models
Zimmer GmbH · 55 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 612
- Deaths reported
- 0
- Injuries reported
- 506
- Recalls
- 0
We found 55 models of Affixus Natural Nail by Zimmer GmbH in the FDA's device registry (GUDID). Together they are named in 612 adverse event reports in the FDA's MAUDE database, received between Dec 24, 2019 and Sep 22, 2026 — classified as 506 injuries, 106 malfunctions.
The most frequently reported specific device problem is “Migration” (389 reports).
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
Most reported Affixus Natural Nail problems
Device problems
- Migration389
- Migration or Expulsion of Device164
- Patient Device Interaction Problem75
- Separation Problem51
- Mechanical Problem34
- Adverse Event Without Identified Device or Use Problem25
- Loosening of Implant Not Related to Bone-Ingrowth16
- Fracture10
Patient problems
- Failure of Implant311
- Insufficient Information167
- Pain154
- No Clinical Signs, Symptoms or Conditions125
- No Code Available24
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available20
- Unspecified Tissue Injury7
- Joint Impingement6
Affixus Natural Nail models
55 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Affixus® Natural Nail® 47-2486-040-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES68 reports
- Affixus® Natural Nail® 47-2486-044-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES57 reports
- Affixus® Natural Nail® 47-2486-046-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES55 reports
- Affixus® Natural Nail® 47-2486-038-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES53 reports
- Affixus® Natural Nail® 47-2486-042-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES52 reports
- Affixus® Natural Nail® 47-2486-036-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES44 reports
- Affixus® Natural Nail® 47-2486-048-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES34 reports
- Affixus® Natural Nail® 47-2496-161-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES29 reports
- Affixus® Natural Nail® 47-2496-160-11ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES24 reports
- Affixus® Natural Nail® 47-2496-160-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES21 reports
- Affixus® Natural Nail® 47-2486-034-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES16 reports
- Affixus® Natural Nail® 47-2486-050-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES14 reports
- Affixus® Natural Nail® 47-2496-240-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- Affixus® Natural Nail® 47-2496-161-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- Affixus® Natural Nail® 47-2496-161-11ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- Affixus® Natural Nail® 47-2496-220-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- Affixus® Natural Nail® 47-2496-160-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- Affixus® Natural Nail® 47-2496-260-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- Affixus® Natural Nail® 47-2486-052-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- Affixus® Natural Nail® 47-2496-221-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- Affixus® Natural Nail® 47-2486-060-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- Affixus® Natural Nail® 47-2486-054-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Affixus® Natural Nail® 47-2486-056-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Affixus® Natural Nail® 47-2486-058-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Affixus® Natural Nail® 47-2488-010-00ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Affixus® Natural Nail® 47-2496-220-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Affixus® Natural Nail® 47-2496-240-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- Affixus® Natural Nail® 110035679ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- Affixus® Natural Nail® 47-2486-122-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2486-124-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2486-126-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2486-128-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2486-065-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2496-221-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2496-240-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2496-241-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2496-260-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2496-261-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2496-280-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2497-280-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 110035650ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 110035672ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- Affixus® Natural Nail® 47-2486-120-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2486-130-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2486-132-40ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2488-000-04ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-200-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-200-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-201-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-220-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-260-09ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-261-08ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 47-2496-280-07ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 110035668ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- Affixus® Natural Nail® 110035674ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent Affixus Natural Nail adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Migration
It was reported that following implantation of an intramedullary nail, a proximal screw backed out approximately one month postoperatively. The event was identified during postoperative follow-up.The patient had no revision planned at the time of the report.Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855691 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
A journal article was obtained on 10-Mar-2026 that reported a retrospective study from the United States. The purpose of the study was to describe a novel technique for treatment of this unique patient population along with its risk of complications and reinfection in patients undergoing staged revision shoulder arthroplasty. The study reviewed 17 patients and 18 shoulders (1 bilateral) between January 2019 and December 2023 who underwent revision for suspected periprosthetic joint infection with proximal humeral bone loss noted preoperatively or at the time of surgery. After removal of the previous implants, a cement spacer was implanted using a OsteoRemedies prefabricated antibiotic humeral head, a Steinmann pin, and a Zimmer Biomet straight humeral nail, and unspecified antibiotic cement to connect the pieces together. The spacer was press-fit into the humeral canal. Second stage reimplantation was considered in cases once patients had completed at least 6 weeks of antibiotics, they had negative inflammatory labs and there was no evidence of wound erythema or drainage. The mean age at the time of spacer placement was 63.6 ± 7.4 years, with an average follow-up of 22.8 ± 16.0 mon
Patient problems: Pain
MAUDE report 50773045 ↗InjurySep 14, 2026Separation Problem
Patient problems: Pain
MAUDE report 50755781 ↗InjurySep 14, 2026Migration
It was reported that the patient underwent an initial procedure. Approximately two weeks post-implantation, a revision surgery was done due a screw that was found to have backed out from its proper position, causing pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50755761 ↗InjurySep 9, 2026Migration
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692633 ↗InjurySep 9, 2026Migration
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692617 ↗InjurySep 9, 2026Separation Problem
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692601 ↗InjurySep 9, 2026Migration
It was reported that three proximal screws backed out approximately two weeks post-implantation. The surgeon monitored the condition and, as the bone had not yet healed, considered a method of re-immobilization. The patient remained under observation, follow-up surgery is being planned, the patient experienced pain.Attempts have been made and no further information has been provided.
Patient problems: Pain
MAUDE report 50692340 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
The clinical study reported that the patient underwent an Initial left humerus open reduction and internal fixation. Subsequently the patient received a steroid injection for subacromial bursitis. Due diligence is in progress for this complaint; to date no additional information or product has been received.
Patient problems: Bursitis
MAUDE report 50340469 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
The clinical study reported that the patient underwent an Initial left humerus open reduction and internal fixation. Subsequently the patient received a steroid injection for subacromial bursitis. Due diligence is in progress for this complaint; to date no additional information or product has been received.
Patient problems: Bursitis
MAUDE report 50340394 ↗InjuryJun 2, 2026Migration
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY AND SUBSEQUENTLY REQUIRED A REOPERATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO PROXIMAL SCREW BACKOUT ASSOCIATED WITH PAIN. DURING FOLLOW-UP APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE, THE SURGEON NOTED THAT PROXIMAL SCREWS IN POSITIONS #1 AND #3 HAD BACKED OUT OF THEIR PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 25363413 ↗InjuryJun 2, 2026Separation Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY AND SUBSEQUENTLY REQUIRED A REOPERATION APPROXIMATELY 3 MONTHS POST-IMPLANTATION DUE TO PROXIMAL SCREW BACKOUT ASSOCIATED WITH PAIN. DURING FOLLOW-UP APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE, THE SURGEON NOTED THAT PROXIMAL SCREWS IN POSITIONS #1 AND #3 HAD BACKED OUT OF THEIR PROPER POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 25363405 ↗MalfunctionMay 20, 2026Migration
IT WAS REPORTED THAT TWO PROXIMAL SCREWS OF AN INTRAMEDULLARY NAIL BACKED OUT APPROXIMATELY TWO MONTHS POSTOPERATIVELY. THE PATIENT WAS MONITORED AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237096 ↗MalfunctionMay 20, 2026Migration
IT WAS REPORTED THAT TWO PROXIMAL SCREWS OF AN INTRAMEDULLARY NAIL BACKED OUT APPROXIMATELY TWO MONTHS POSTOPERATIVELY. THE PATIENT WAS MONITORED AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237094 ↗MalfunctionMay 20, 2026Separation Problem
IT WAS REPORTED THAT TWO PROXIMAL SCREWS OF AN INTRAMEDULLARY NAIL BACKED OUT APPROXIMATELY TWO MONTHS POSTOPERATIVELY. THE PATIENT WAS MONITORED AND NO REVISION WAS PLANNED. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237083 ↗
Other Zimmer GmbH products
- Biolox delta16 models · 343 reports
- NCB78 models · 200 reports
- Zimmer Natural Nail System57 models · 187 reports
- Biolox Option16 models · 68 reports · 2 recalls
- Avenir24 models · 57 reports · 1 recall
- Anatomical Shoulder33 models · 102 reports
- Sidus Stem-Free Shoulder9 models · 30 reports · 1 recall
- Wagner SL Revision33 models · 66 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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