Hazard

Device Fracture recalls

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

What the numbers show

Total: 63
Critical: 7
Severe: 30
Most recent: 2026-07-01

Of the 63 device fracture recalls we have scored against our rubric, 7 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 30 (48%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device fracture 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.

51–63 of 63

HighFDA (Devices)·Z-2155-2014·2014-08-20
Cardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.
Product
CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in pa
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0421-2014·2013-12-04
DePuy Orthopaedics Recalls HP M.B.T. Keel Punch Knee Instruments
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0416-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0422-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0418-2014·2013-12-04
DePuy Recalls HP M.B.T. Keel Punch Knee Instruments Due to Fracture Risk
DePuy Orthopaedics is voluntarily recalling HP M.B.T. Keel Punch Knee Instruments because tabs on the connection end may fracture and remain in the patient.
Product
SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used during total knee arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2014·2013-11-13
Stryker Recalls Dekompressor Percutaneous Discectomy Probes Due to Fracture Risk
Stryker is recalling Dekompressor Percutaneous Discectomy Probes because the auger or cannula may fracture if the device is manually bent, potentially requiring additional medical intervention.
Product
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1953-2013·2013-08-21
Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture
Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.
Product
REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1275-2013·2013-05-22
Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent
Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.
Product
Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an art
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1274-2013·2013-05-22
Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent Due to Catheter Fracture
Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents because the delivery system's inner catheter can fracture or separate after deployment, a defect linked to one reported death.
Product
Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an ar
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0141-2013·2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 2,560 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
Product
SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0151-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 6.5 anchors because they may fracture after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0154-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 6.5 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 4,151 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0146-2013·2012-10-31
DePuy Mitek Recalls 94 SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 94 SpiraLok 6.5mm anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
Category
Medical Device
Distribution
Distributed nationwide