FDA (Devices) recall action 98069

Zimmer, Inc. recalled 17 products on 2025-12-31

The FDA (Devices) publishes a recall like this one as 17 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 17 pages.

Products: 17
Announced: 2025-12-31
Critical: 0
Units: 347

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–17 of 17

HighFDA (Devices)··2025-12-31
Femoral nails, 360 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509360, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 300 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815509300, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 300 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 11 Affixus Antegrade Femoral Nails, model 815609300, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 420 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509420, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 400 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Ritz peanut butter cracker sandwiches recalled over undeclared peanut from mispackaging
Mondelez Global is recalling 70 cases of Ritz Peanut Butter Cracker Sandwiches over undeclared peanut due to mispackaging.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 320 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509320, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Neurostimulator programmer app recalled over a device reset message that persisted
Medtronic Neuromodulation is recalling 7,667 Restore Clinician Programmer Application devices after a Device Reset message could not be cleared, in rare cases preventing therapy from resuming.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 440 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 400 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609400, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 340 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 440 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 24 Affixus Antegrade Femoral Nails, model 815609440, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 420 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609420, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 380 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815509380, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 320 mm left trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 23 Affixus Antegrade Femoral Nails, model 815609320, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 340 mm right trochanteric, recalled over undersized shaft diameter
Zimmer is recalling 22 Affixus Antegrade Femoral Nails, model 815509340, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
Category
Distribution
14 states
HighFDA (Devices)··2025-12-31
Femoral nails, 280 mm left piriformis, recalled over undersized shaft diameter
Zimmer is recalling 3 Affixus Antegrade Femoral Nails, model 815809280, because an undersized distal shaft diameter could lead to implant fatigue fracture.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A
Category
Distribution
14 states