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Howmedica Osteonics Recalls
232 recalls on record · September 21, 2016 to June 24, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 24, 2026Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
Hazard: Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
June 24, 2026Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
Hazard: Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
March 25, 2026Medical DevicesFDA
Howmedica Osteonics Corp. recalls MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
Hazard: A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
December 31, 2025Medical DevicesFDA
Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infr
Hazard: When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
October 8, 2025Medical DevicesFDA
Howmedica Osteonics Corp. recalls 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0
Hazard: a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
October 16, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Hazard: Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
October 16, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications dur
Hazard: Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
September 4, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100
Hazard: A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
July 24, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number:
Hazard: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
July 24, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number:
Hazard: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
July 24, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number:
Hazard: Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
June 26, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Hazard: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
June 26, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Hazard: The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including re-use and re-sterilization of the single-use, sterile-packaged instruments.
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Cata
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalo
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog N
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Nu
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
May 1, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog
Hazard: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 7 9 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.