The Recall Desk

Manufacturer

Howmedica Osteonics Corp.

232 recalls in our database name Howmedica Osteonics Corp. as the manufacturing or recalling firm.

What the numbers show

Total
232
Critical
0
Severe
13
Most recent
2026-06-24

Of the 232 recalls from Howmedica Osteonics Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 13 (6%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

126–150 of 232

  • ModerateFDA (Devices)·Z-2094-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2097-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 66 right, Sterile, Catalog # 504-02-66F-R, UDI (01)07613327012477(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2086-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Shells because the device may fall off its post in the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2089-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose components and coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2088-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recalled for Packaging Defect

    Howmedica Osteonics is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in loose coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2091-2020·2020-05-27

    Stryker Restoration Anatomic Shell Recall Due to Packaging Defect

    Howmedica Osteonics Corp. is recalling Stryker Restoration Anatomic Hemispherical Shells because the device may fall off its post within the inner packaging, resulting in coating debris.

    Product
    Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1900-2020·2020-05-13

    Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations

    Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.

    Product
    Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0811-2020·2020-01-22

    Stryker Omnifit Crossfire Hip Insert Recall Due to Missing Locking Wire

    Howmedica Osteonics Corp. is recalling 20 units of Stryker Omnifit Crossfire 10 Degree Series II Inserts due to a potential missing locking wire.

    Product
    Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0514-2020·2019-12-04

    Stryker X-Change Medial Wall Mesh Small Recall for Incorrect Contents

    Howmedica Osteonics Corp. is recalling 40 units of Stryker X-Change Medial Wall Mesh Small (6-Petal) because boxes contain the 4-Petal version instead.

    Product
    Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2757-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 167 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 LEFT Catalog # 5541-A-201 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2760-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 159 units of Triathlon Femoral Distal Augments because a device overhang protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 171 units of Triathlon Femoral Distal Augments due to a device overhang issue that protrudes beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 10MM - SIZE 2 RIGHT Catalog # 5541-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2019·2019-10-09

    Howmedica Recalls Triathlon Femoral Distal Augments Due to Device Overhang

    Howmedica Osteonics Corp. is recalling 153 units of Triathlon Femoral Distal Augments because a device overhang issue causes them to protrude beyond the mating femoral component.

    Product
    TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision Total Knee Arthroplasty (TKA) and with Triathlon Primary PS Femoral Components during TKA to address distal femoral defects. (See att
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2160-2019·2019-08-14

    Howmedica Serrato Polyaxial Screws Recalled for Incorrect Length

    Howmedica Osteonics Corp. is recalling 11 Serrato polyaxial screws because some 90mm and 100mm units were manufactured with the wrong length.

    Product
    Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0657-2019·2018-12-26

    Howmedica Recalls Reliance LITe Nerve Hooks Due to Shape Defects

    Howmedica Osteonics Corp. is recalling 39 units of Reliance LITe Nerve Hooks because the probes have incorrect shapes, including flat surfaces and sharp edges.

    Product
    Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF p
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0605-2019·2018-12-19

    Howmedica Recalls Tritanium Posterior Lumbar Cage Implants Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling 28,461 Tritanium Posterior Lumbar cage implants because of reports of fractures occurring during or after surgery.

    Product
    Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0373-2019·2018-11-14

    Howmedica Recalls 15 Pouches of Sterile Knee Instruments Due to Barrier Risk

    Howmedica Osteonics Corp. is recalling 15 pouches of sterile knee instruments because the outer sterile barrier may be compromised.

    Product
    Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0207-2019·2018-10-31

    Howmedica Recalls Tritanium TL Steerable Inserter Due to Locking Mechanism Failure

    Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter because the locking mechanism may fail to function as intended due to lack of lubrication.

    Product
    Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2716-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.

    Product
    #2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2690-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2717-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.

    Product
    rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2685-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns

    Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2703-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Howmedica Osteonics Corporation

Source: Wikidata (Q127687850), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.