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.

51–75 of 150

SevereFDA (Devices)·Z-1241-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 90mm Material Number: 66-590 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1231-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recall for Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 72mm Material Number: 66-472 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1216-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 36mm Material Number: 66-236 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1232-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate during or after surgery, requiring revision.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 4Level, 76mm Material Number: 66-476 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1224-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 54mm Material Number: 66-354 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1238-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 75mm Material Number: 66-575 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1211-2021·2021-03-17
CervAlign Anterior Cervical Plate System Recalled for Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 2Level, 24mm Material Number: 66-224 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1226-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 60mm Material Number: 66-360 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1236-2021·2021-03-17
Pioneer Surgical Technology Recalls CervAlign Anterior Cervical Plate System
RTI Surgical, Inc. is recalling the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 100mm Material Number: 66-5100 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration o
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1209-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System Due to Locking Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 20mm Material Number: 66-120 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1239-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific CervAlign Anterior Cervical Plate Systems because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 5 Level, 80mm Material Number: 66-580 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1208-2021·2021-03-17
FDA Recalls CervAlign Anterior Cervical Plate System Due to Locking Mechanism Failure
RTI Surgical is recalling specific batches of the CervAlign Anterior Cervical Plate System because the locking mechanism may disassociate, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 1 Level, 18mm Material Number: 66-118 - Product Usage: intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0921-2021·2021-02-03
OMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts
OMNIlife Science Inc. is recalling 3 units of SERF Novae Dual Mobility Cup Inserts due to high oxidation levels that may increase wear rates and require revision surgery.
Product
SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0922-2021·2021-02-03
OMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
OMNIlife science Inc. is recalling 2 units of SERF Novae Dual Mobility Cup Inserts because they have higher than acceptable oxidation limits, which may increase wear rates and require revision surgery.
Product
SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0920-2021·2021-02-03
OmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
OmnIlife Science is recalling three units of SERF Novae Dual Mobility Cup Inserts because they exceed acceptable oxidation limits, potentially increasing wear rates and the need for revision surgery.
Product
SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-3021-2020·2020-10-07
Encore Medical Recalls Mislabeled Humeral Socket Inserts
Encore Medical is recalling 15 units of RSP Standard Humeral Socket Inserts due to size labeling discrepancies that could lead to incorrect implantation.
Product
RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-2481-2019·2019-09-11
OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
OMNIlife science Inc. is recalling six ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
Product
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2479-2019·2019-09-11
OMNIlife ApeX Acetabular Liner Recalled for Oxidation Testing Failure
OMNIlife science Inc. is recalling 14 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
Product
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2480-2019·2019-09-11
OMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
OMNIlife science Inc. is recalling 22 ApeX acetabular liners that failed oxidation testing. The defect may cause higher wear rates, potentially leading to revision surgery.
Product
OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1123-2019·2019-04-17
Encore Medical Recalls Exprt Precision System Hip Implant Components
Encore Medical is recalling 22 units of Exprt Precision System hip implant components due to loose or improperly seated bolts that may cause pain or require revision surgery.
Product
Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0003-2019·2018-10-10
Smith & Nephew Recalls JOURNEY BCS Knee Polyethylene Inserts
Smith & Nephew is recalling JOURNEY BCS Knee Conventional Polyethylene Inserts due to elevated revision rates reported in international joint registries.
Product
JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 7402313
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0001-2019·2018-10-10
Smith & Nephew Recalls Journey BCS Knee CoCr Femoral Components
Smith & Nephew is recalling Journey BCS Knee CoCr Femoral Components because registry data indicates the first-generation system has a revision rate over 1.5 times the class average.
Product
Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0002-2019·2018-10-10
Smith & Nephew Recalls Journey BCS Oxinium Knee Femoral Components
Smith & Nephew is recalling Journey BCS Oxinium knee femoral components due to elevated revision rates reported in international joint registries.
Product
JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 7402113
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2716-2018·2018-08-15
Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants
Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.
Product
#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2703-2018·2018-08-15
Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide