Hazard

Implant recalls

74 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 74
Critical: 3
Severe: 0
Most recent: 2026-06-24

Of the 74 implant recalls we have scored against our rubric, 3 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all implant recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 74

HighFDA (Devices)·Z-0974-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0972-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0971-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0996-2026·2025-12-31
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.
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0973-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0979-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0976-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0981-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0980-2026·2025-12-31
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
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0255-2026·2025-12-17
Knee fusion nail components recalled over a locking screw inserted backwards
Waldemar Link is recalling 18 Endo Model Knee Fusion Nail SK coupling components delivered with a preassembled locking screw inserted from the wrong side into the male taper.
Product
Deep-brand Premium Select Karela Ring Cut KEEP FROZEN Net Wt. 12 oz. (340 g)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0871-2026·2025-12-10
Fibula nails recalled over out of specification thread depths on the implant
Paragon 28 is recalling 20 Phantom Fibula Nails because out of specification thread depths may prevent the implant from mating with its mounting bolt, potentially requiring surgery to be aborted.
Product
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0531-2026·2025-12-03
Pericardial patches recalled because a lot may not meet tensile strength
Glycar SA is recalling 30 SJM Pericardial Patches with EnCap Technology because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Product
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0532-2026·2025-12-03
Smaller pericardial patches recalled over a tensile strength specification failure
Glycar SA is recalling 18 SJM Pericardial Patches, 5 x 10 cm, because the impacted lot may not meet the required tensile strength specification. The FDA classified it Class I.
Product
SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0540-2026·2025-11-26
Bone void implants recalled over an incorrect product name on packaging
Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.
Product
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0459-2026·2025-11-19
Deep brain stimulators recalled over loss of programmer communication
Abbott Medical is recalling 722 Liberta RC deep brain stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
Product
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0478-2026·2025-11-19
Spinal fixation screws recalled for not meeting performance standards
Orthofix is recalling 624 Virata preassembled polyaxial screws used in the Virata Spinal Fixation System because the screws do not meet performance standards.
Product
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0458-2026·2025-11-19
Spinal cord stimulators recalled over loss of programmer communication
Abbott Medical is recalling 20,715 Eterna spinal cord stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.
Product
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0418-2026·2025-11-12
Hip bearings recalled because size F packages contain size G implants
Zimmer is recalling 72 Dual Mobility Vivacit-E bearings labelled Size F 44 mm because the implant inside the package is a Size G 46 mm, and the reverse also occurred.
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0432-2026·2025-11-12
Hip bipolar heads recalled over packaging that may compromise sterility
Total Joint Orthopedics is recalling 103 Klassic BiPolar Heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
Product
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2026·2025-11-12
Size G hip bearings recalled over commingled implant sizes in packaging
Zimmer is recalling 63 Dual Mobility Vivacit-E bearings labelled Size G 46 mm because the package contents and label may be commingled with the Size F 44 mm bearing.
Product
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0417-2026·2025-11-12
Dental implant screws recalled because the wrong screw was packaged
Prismatik Dentalcraft is recalling 208 Inclusive Titanium Screws because an incorrect titanium screw was packaged with the dental implant.
Product
Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-0316-2026·2025-11-05
Soft tissue markers recalled over potential contamination with cotton fibers
Endomagnetics is recalling 1,760 Magseed Pro 7 cm soft tissue markers because of the potential for contamination with cotton fibers.
Product
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0317-2026·2025-11-05
Magseed Pro 12 cm markers recalled over potential cotton fiber contamination
Endomagnetics is recalling 540 Magseed Pro 12 cm soft tissue markers because of the potential for contamination with cotton fibers.
Product
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0212-2026·2025-10-29
AC joint fixation implants recalled over potentially missing slotted button assembly
Biomet is recalling 98 ZipTight Acute AC Joint Implants from one lot because of the potential for a missing slotted button assembly.
Product
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0227-2026·2025-10-29
Bipolar hip heads recalled downstream after femoral components failed transit testing
Theken Companies is recalling 409 iNSitu Bipolar Hip System head assemblies in a downstream recall after BioPro femoral components failed transit testing, risking sterile barrier issues.
Product
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Asse
Category
Medical Device
Distribution
Distributed nationwide