Hazard

Revision Surgery recalls

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

What the numbers show

Total: 150
Critical: 0
Severe: 76
Most recent: 2026-08-12

Of the 150 revision surgery recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 76 (51%) 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 revision surgery 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.

126–150 of 150

HighFDA (Devices)·Z-0450-2016·2015-12-30
Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect
Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.
Product
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-2743-2015·2015-10-07
MicroPort Recalls Profemur Plus Modular Neck Hip Prosthesis Components
MicroPort Orthopedics is recalling Profemur Plus modular neck hip prosthesis components due to an unexpected rate of postoperative fractures requiring revision surgery.
Product
PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper. Orthopedic hip prosthesis component.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2746-2015·2015-09-16
Smith & Nephew Birmingham Hip Resurfacing Acetabular Cup Recalled
Smith & Nephew is recalling specific Birmingham Hip Resurfacing Acetabular Cups because the system's revision rates were higher than established benchmarks.
Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Us
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2747-2015·2015-09-16
Smith & Nephew Birmingham Hip Resurfacing Dysplasia Cup Recall
Smith & Nephew is recalling Birmingham Hip Resurfacing Dysplasia Cups because the system showed higher revision rates than established benchmarks.
Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2745-2015·2015-09-16
Smith & Nephew Birmingham Hip Resurfacing Femoral Head Recall
Smith & Nephew is recalling 5,987 units of the Birmingham Hip Resurfacing Femoral Head due to revision rates higher than established benchmarks.
Product
Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1944-2015·2015-07-08
Biomet Recalls Gentle Threads Interference Screws Due to Lot Mixing
Biomet is recalling 53 units of Gentle Threads Interference Screws because they were mixed with a different size, posing a risk of surgical failure.
Product
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1744-2015·2015-06-17
Biomet Optigun Ratchet Cement Gun Recalled Due to Pin Disconnection Risk
Biomet France is recalling three Optigun Ratchet cement guns because a pin may disconnect and be lost, potentially delaying surgery or requiring revision.
Product
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1672-2015·2015-06-03
DePuy LCS COMPLETE RPS Femoral Implants Recalled for Patello-femoral Pain Risk
DePuy Orthopaedics is recalling 19,059 LCS COMPLETE RPS Femoral Implants because they are associated with higher revision rates and potential patello-femoral pain when the native patella is not resurfaced.
Product
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1314-2015·2015-04-01
Flower Orthopedics Recalls Variable Angle Locking Pegs Due to Failure
Flower Orthopedics is recalling 901 Variable Angle Locking Pegs because they failed to lock during distal radius procedures, resulting in one scheduled revision surgery.
Product
Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1042-2015·2015-02-11
Zimmer Persona Tibial Inserter Recalled for Potential Tip Fracture
Zimmer, Inc. is recalling 1,091 Persona Tibial Articular Surface Inserters due to a potential fracture of the instrument tip, which could cause tissue damage or require revision surgery.
Product
Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2014·2014-05-21
Biomet ExploR Radial Stem Recalled for Missing Threads
Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.
Product
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1736-2013·2013-07-24
Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
Integra LifeSciences is recalling PANTA Arthrodesis Nail Systems due to screw misalignment that may require revision surgery.
Product
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0921-2013·2013-03-20
Genesys Orthopedic Recalls 3.75mm Fixed Cervical Screws Due to Manufacturing Residue
Genesys Orthopedic Systems is recalling 3.75mm x 12mm Fixed Cervical Screws because manufacturing residue may be present. The residue poses risks of infection, delayed fusion, or revision surgery.
Product
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
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
SevereFDA (Devices)·Z-0149-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers all lot codes distributed worldwide.
Product
SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 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-0150-2013·2012-10-31
DePuy Mitek Recalls Seven SpiraLok 6.5 Anchors Due to Fracture Risk
DePuy Mitek is recalling seven SpiraLok 6.5 anchors because they fractured after surgery, requiring patients to undergo revision procedures.
Product
SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 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-0145-2013·2012-10-31
SpiraLok 5.0mm Anchors Recalled for Post-Operative Fracture Risk
DePuy Mitek is recalling 232 units of SpiraLok 5.0mm anchors due to post-operative fractures requiring patient revision surgery.
Product
SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 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-0142-2013·2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 314 units of SpiraLok 6.5mm anchors because they may fracture after surgery, requiring patients to undergo revision surgery.
Product
SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 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-0144-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0mm Anchors Due to Fracture Risk
DePuy Mitek is recalling 400 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 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-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-0155-2013·2012-10-31
DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 4,321 units of SpiraLok 6.5 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 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-0152-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 25,393 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision.
Product
SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 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-0153-2013·2012-10-31
DePuy Mitek Recalls SpiraLok 5.0 Anchors Due to Post-Operative Fracture
DePuy Mitek is recalling 39,362 units of SpiraLok 5.0 anchors because they may fracture after surgery, requiring revision. The recall covers worldwide distribution.
Product
SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 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