Femoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609360, because an undersized distal shaft diameter could lead to implant fatigue fracture.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states an undersized shaft could cause implant fatigue fracture requiring surgical intervention, and no injuries are reported.
Plain-English summary
The Affixus Antegrade Femoral Nail, model 815609360, described in the record as Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail, is being recalled by Zimmer, Inc.
Affected implants may have an undersized distal diameter along the length of the shaft, which the firm states could lead to implant fatigue fracture. Zimmer lists the potential health risks if an implant fatigue fracture occurs as adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.
The record lists 24 units, carrying UDI-DI (01)00887868144493(17)340820(10)66717603 from lot 66717603. Distribution was nationwide in the United States, in Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas and Utah. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Zimmer's instructions.
The recalled product
- Product
- Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E P
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 7,667
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- SevereEnhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator
FDA (Devices) · 2025-05-07
Same hazard · undersized component
See all →- HighAnti-Torque Instrument in Vector Pedicle Screw System Recalled
FDA (Devices) · 2026-08-12
- HighFemoral nails, 360 mm right trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
- HighFemoral nails, 300 mm right trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
- HighFemoral nails, 300 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
- HighFemoral nails, 420 mm right trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31