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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

353

Class I (Serious)

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 1681–1700 of 3680 recalls

X-Change Wall Mesh (Howmedica Osteonics) – Incorrect Mesh Type (2019)

Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)

FDAOct 3, 2019Nationwide• Howmedica Osteonics Corp.

Sterile Disposable Fleece Drape (Aesculap) – Packaging Sterility Issue (2019)

Packaging seal integrity not validated resulting in a lack of sterility assurance.

FDAOct 1, 2019Nationwide• Aesculap Implant Systems LLC

TC Cooely Micro Needleholder (Aesculap) – Incorrect Size Label (2019)

Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.

FDASep 25, 2019Nationwide

1...83 848586 87...184

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• Aesculap Implant Systems LLC

Midline Basic Tray (Vygon) – Incorrect Catheter Size (2019)

Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

FDASep 24, 2019IN, TN• Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

ARENA TTA2 Software (Tomtec) – Interface Problem (2019)

The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.

FDASep 23, 2019AL, AZ, CA +12 more• Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany

DABRA Catheter (Ra Medical Systems) – Calibration Failure (2019)

The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.

FDASep 19, 2019Nationwide• Ra Medical Systems, Inc.

Forte Gamma Camera (Philips) – Detector Safety Risk (2019)

An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.

FDASep 19, 2019Nationwide• Philips Medical Systems (Cleveland) Inc

MotoBand CP Screw (CrossRoads) – Incorrect Screw Size (2019)

Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.

FDASep 19, 2019Nationwide• CrossRoads Extremity Systems, LLC

SE Grocers Variety Pack Cookies (Southeastern Grocers) – undeclared peanuts (2019)

18 count Variety Pack cookies made in-store bakeries included Peanut Butter cookies which were not declared on PDP or ingredient list

Class IHigh

FDASep 17, 2019AL, GA, IN +4 more• SOUTHEASTERN GROCERS - MARKETI

SE Grocers Peanut Butter Cookies (Southeastern Grocers) – undeclared peanuts (2019)

18 count Peanut Butter cookies made in-store bakeries failed to declare peanuts on ingredient labels.

Class IIModerate

FDASep 17, 2019AL, GA, IN +4 more• SOUTHEASTERN GROCERS - MARKETI

Infinity Acute Care System (Draegar) – Cybersecurity Vulnerability (2019)

Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.

FDASep 13, 2019Nationwide• Draegar Medical Systems, Inc.

Sheath Introducer Kit (Merit Medical) – Labeling Error (2019)

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

FDASep 12, 2019Nationwide• Merit Medical Systems, Inc.

Pharos Excimer Laser (RA MEDICAL) – Software Dosage Error (2019)

At doses of less than 100 mJ, in custom and auto repeat modes, a software error in the excimer laser phototherapy system causes the device to fail to cease firing as long as the foot pedal or handpiece switch is depressed. This malfunction can cause overtreatment, which could result in strong erythema, and possibly cause blisters.

FDAAug 23, 2019Nationwide• Ra Medical Systems, Inc.

Roadmaster RM852 EM Tire (ROADMASTER) – Sidewall Integrity Risk (2019)

Cooper Tire & Rubber Co. (Cooper Tire) is recalling certain Roadmaster RM852 EM tires, size 295/75R22.5, with DOT date codes 4618 through 4818. The innerliner gauge may be too thin, allowing the tire sidewall to fail.

NHTSAAug 23, 2019Nationwide• ROADMASTER

Safety Needle Sets (Repro-Med) - Mislabeled Length (2019)

Mislabeled needle lengths

FDAAug 20, 2019Nationwide• Repro-Med Systems, Inc.

Triathlon Femoral Augment (Osteonics) - Device Overhang (2019)

Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component

FDAAug 19, 2019Nationwide• Howmedica Osteonics Corp.

Grab n Go VIPR System (Western Scott Fetzer) - Control Knob Issue (2019)

Limited access to flow settings as a result of the control knob having been rotated beyond its functional range

FDAAug 15, 2019Nationwide• Western Scott Fetzer Company

Varian Multileaf Collimator (Varian) – Software Movement Issue (2019)

After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- secondary interlock due to carriage fault on the MLC that immediately preceded the initiation of the arc treatment. The issue will occur only with MLC software version 8.5 and only affects conformal arc treatments, including VMAT and RapidArc. There have been no reports of adverse health consequences due to this issue.

FDAAug 12, 2019Nationwide• Varian Medical Systems, Inc.

Aesculap Caiman Instrument (Aesculap) – Sterilization Concern (2019)

possibility of the sterility batch being insufficiently sterilized

FDAAug 7, 2019Nationwide• Aesculap Implant Systems LLC

Body Weight Support (MOTEK MEDICAL) – Manufacturing Deviation (2019)

The firm discovered a potential manufacturing deviation of the yoke of the Body Weight Support (BWS) Light that in rare occasions may result in the yoke detaching from the cable guide.

FDAJul 29, 2019Nationwide• MOTEK MEDICAL B.V. Hogehilweg 18 18 Unit C Amsterdam Netherlands