AffixusRecalls & reported problems across all models
Zimmer, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
17 open recalls name at least one Affixus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 17
We found 18 models of Affixus by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Aug 12, 2026 and Aug 12, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (1 report).
17 FDA recall records name at least one of these models by its device identifier, 17 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
Affixus 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.
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0983-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0982-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0981-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0980-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0979-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0978-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0977-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0976-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0975-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0974-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0973-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0972-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0971-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0970-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0969-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0968-2026 · Root cause: Process design · Recall details · FDA record ↗
- Dec 2, 2025Open, Classified
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
Z-0967-2026 · Root cause: Process design · Recall details · FDA record ↗
Most reported Affixus problems
Device problems
- Fracture1
Patient problems
- Foreign Body In Patient1
Affixus models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Affixus® 815509300ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815509320ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815509340Screw, fixation, bone1 recall0 reports
- Affixus® 815509360Screw, fixation, bone1 recall0 reports
- Affixus® 815509380ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815509400Screw, fixation, bone1 recall0 reports
- Affixus® 815509420ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815509440Screw, fixation, bone1 recall0 reports
- Affixus® 815609300Screw, fixation, bone1 recall0 reports
- Affixus® 815609320Screw, fixation, bone1 recall0 reports
- Affixus® 815609340Screw, fixation, bone1 recall0 reports
- Affixus® 815609360Screw, fixation, bone1 recall0 reports
- Affixus® 815609380ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815609400ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815609420ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 815609440Screw, fixation, bone1 recall0 reports
- Affixus® 815809280ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- Affixus® 211300080REAMER1 report
Recent Affixus adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Fracture
It was reported that, when reaming the tibial canal, the reamer head became stuck on the guide wire. It detached from the reamer shaft and pieces of the retaining mechanism broke off and were left in the patient¿s tibia. There was no delay to the procedure. Surgical technique was used. It was reported that no further information is available.
Patient problems: Foreign Body In Patient
MAUDE report 50229609 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
- Comprehensive18 models · 103 reports · 3 recalls
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.
How reports and recalls are matched · Editorial policy · Report an error on this page