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Howmedica Osteonics Corp.

Howmedica Osteonics Corp. Recalls

All product recalls associated with Howmedica Osteonics Corp..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

34

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3001–3020 of 21320 recalls

Howmedica Trident Poly Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Dur PCA MTK Rev Insert Left (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Soltive Laser Fibers (Olympus) – Cleaning Instructions (2023)

Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

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FDADec 1, 2023Nationwide• Olympus Corporation of the Americas

P7 32mm Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

P7 28mm Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Scorpio-Flex Total Knee Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

Primary Rev Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

PS Lipped Tibial Insert (Howmedica) – Material Oxidation Risk (2023)

Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.

FDADec 1, 2023Nationwide• Howmedica Osteonics Corp.

ZOOM LATITUDE Programmer (Boston Scientific) – Diagnostic Date Display (2023)

The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.

FDANov 30, 2023Nationwide• Boston Scientific Corporation

BrightView XCT (Philips) – Scan Motion Gap (2023)

Laceration Risk

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

FDANov 30, 2023Nationwide• Philips North America

GammaPod Treatment System (Xcision) – Planning Software Error (2023)

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

FDANov 30, 2023Nationwide• Xcision Medical Systems, LLC

bkActiv Ultrasound System (B-K Medical) – Measurement Error (2023)

An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

FDANov 30, 2023Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Spectral CT 7500 (Philips) – Software Functionality (2023)

Multiple software issues that affect device functionality.

FDANov 30, 2023Nationwide• Philips North America Llc

BrightView Gamma Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

FDANov 30, 2023Nationwide• Philips North America

BrightView X Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

FDANov 30, 2023Nationwide• Philips North America

Sensis Vibe Hemo (Siemens) – Documentation Crash (2023)

The possibility of the Sensis documentation functionality application to crash.

FDANov 29, 2023CA, CT, FL• Siemens Medical Solutions USA, Inc

Cardiac Procedural Kits (American Contract) – Sterilization Issue (2023)

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Anesthesia Procedural Kits (American Contract) – Sterilization Issue (2023)

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Cortera Spinal Fixation System (XTANT) – Screw Shank Incorrect (2023)

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.

FDANov 28, 2023IN, MI• XTANT Medical Holdings, Inc

Patient Information Center (Philips) – Push Notification Failure (2023)

Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.

FDANov 28, 2023Nationwide• Philips North America