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.

1–25 of 150

HighFDA (Devices)·Z-2907-2026·2026-08-12
Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2902-2026·2026-08-12
Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2026·2026-06-24
Inspire stimulation leads labeled with Use By dates beyond shelf life
Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.
Product
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2456-2026·2026-06-24
TRIGEN proximal humeral nails are missing their distal holes
TRIGEN Proximal Straight Humeral Nails 8/7 x 16 are being recalled because a manufacturing error left them missing distal holes. Five units are affected.
Product
TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2515-2026·2026-06-24
Inspire respiratory sensing leads labeled with Use By dates beyond shelf life
Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.
Product
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pres
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1521-2026·2026-03-18
Link Endo-Model plateau 15-0027/11 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1516-2026·2026-03-18
Link Endo-Model plateau 15-2836/11 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2836/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-2836/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1519-2026·2026-03-18
Link Endo-Model plateau 15-8521/11 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/11;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1522-2026·2026-03-18
Link Endo-Model plateau 15-0027/12 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1523-2026·2026-03-18
Link Endo-Model plateau 15-0027/16 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/16 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/16;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1515-2026·2026-03-18
Link Endo-Model plateau 15-2835/12 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2835/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-2835/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1514-2026·2026-03-18
Link Endo-Model SL connection component recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/07 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1518-2026·2026-03-18
Link Endo-Model plateau 15-8521/09 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/09 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1512-2026·2026-03-18
Link Endo-Model plateau 15-0027/15 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-0027/15;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1520-2026·2026-03-18
Link Endo-Model plateau 15-8521/15 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-8521/15;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1513-2026·2026-03-18
Link Endo-Model SL component 16-2840/02 recalled over bushing fracture
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/02 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1511-2026·2026-03-18
Link Endo-Model SL component 16-2840/05 recalled over bushing fracture
Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/05 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1517-2026·2026-03-18
Link Endo-Model plateau 15-8030/12 recalled over screw bushing fracture
Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8030/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.
Product
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1480-2026·2026-03-11
Implantable collamer lenses recalled after being labeled with wrong length
Staar Surgical is recalling seven EVO+ Visian Toric Implantable Collamer Lenses that were labeled as 12.1 mm but are 12.6 mm, creating the potential for excessive vault.
Product
EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2126-2025·2025-07-23
EMPOWR 3D knee tibial inserts were packaged with the wrong implant
EMPOWR 3D Knee Tibial Insert E-PLUS units are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units are affected.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2125-2025·2025-07-23
EMPOWR 3D knee 10mm tibial inserts were packaged with wrong implant
EMPOWR 3D Knee Tibial Insert E-PLUS units, catalog number 341-10-711, are being recalled because of a packaging discrepancy in which incorrect tibial inserts were packaged. 20 units affected.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty p
Category
Medical Device
Distribution
18 states
SevereFDA (Devices)·Z-1240-2021·2021-03-17
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, 85mm Material Number: 66-585 - 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-1225-2021·2021-03-17
RTI Surgical Recalls CervAlign Anterior Cervical Plate System
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, 57mm Material Number: 66-357 - 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-1223-2021·2021-03-17
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, requiring revision surgery.
Product
CervAlign Anterior Cervical Plate System-Cervalign, 3Level, 51mm Material Number: 66-351 - 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-1242-2021·2021-03-17
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, 95mm Material Number: 66-595 - 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