Hazard

Instrument Breakage recalls

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

What the numbers show

Total: 12
Critical: 0
Severe: 2
Most recent: 2023-06-21

Of the 12 instrument breakage recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (17%) 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 instrument breakage 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.

1–12 of 12

HighFDA (Devices)·Z-1972-2023·2023-06-21
Driver Instrument May Break During Surgery, Leaving Metal Fragments
The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.
Product
Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2025-2020·2020-05-27
K2M Aleutian Lordotic Spreader Recalled Due to Tip Breakage Risk
K2M, Inc. is recalling Aleutian Lordotic Spreader Systems because the welded tips may break off during spinal procedures.
Product
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal impla
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1216-2018·2018-04-04
Stryker Recalls Thoracic Pedicle Feelers Due to Potential Tip Breakage
Stryker is voluntarily recalling 28 Thoracic Pedicle Feelers because machine settings caused material degradation, creating a risk that the instrument tip may break.
Product
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Ped
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2667-2017·2017-07-12
Exactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming
Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.
Product
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2666-2017·2017-07-12
Exactech Equinoxe Modular Reverse Pilot-Tip Reamer Recall for Labeling Clarification
Exactech is recalling Equinoxe Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Product
EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2668-2017·2017-07-12
Exactech Equinoxe Reamer Recall Due to Updated Instructions for Use
Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Product
EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2662-2017·2017-07-12
Exactech Recalls Logic Fit Tibial Tamp Heads for Labeling Clarification
Exactech, Inc. is recalling 573 Logic Fit Tibial Tamp Heads to update surgical labeling. The update clarifies proper removal techniques to prevent instrument breakage.
Product
Logic Fit Tibial Tamp Head
Category
Medical Device
Distribution
32 states
ModerateFDA (Devices)·Z-2664-2017·2017-07-12
Exactech Equinoxe Glenoid Reamer Recalled for Updated Instructions
Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Product
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2663-2017·2017-07-12
Exactech Equinoxe Reverse Starter Reamer Recalled for Updated Instructions
Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Product
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2665-2017·2017-07-12
Exactech Equinoxe Modular Reverse Pilot-Tip Starter Reamer Recall
Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent instrument breakage.
Product
EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2644-2017·2017-07-05
Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification
Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.
Product
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for trans
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1565-2014·2014-05-14
SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.
Product
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter as
Category
Medical Device
Distribution
Distributed nationwide