The Recall Desk

Manufacturer

Stryker Howmedica Osteonics Corp.

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

What the numbers show

Total
87
Critical
0
Severe
8
Most recent
2017-05-31

Of the 87 recalls from Stryker 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 8 (9%) 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.

26–50 of 87

  • ModerateFDA (Devices)·Z-0873-2016·2016-03-02

    Stryker T2 K-Wire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2016·2016-03-02

    Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0875-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0877-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review indicated that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2016·2016-03-02

    Stryker T2 Guidewire Recalled for Potential Pouch Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0878-2016·2016-03-02

    Stryker T2 Guidewire Recalled for Potential Packaging Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.

    Product
    Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2016·2016-03-02

    Stryker T2 Guidewire Recalled Due to Potential Pouch Seal Integrity Issues

    Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.

    Product
    Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0362-2016·2015-12-09

    Stryker Duracon Tibial Wedge Implants Recalled for Packaging Integrity Issues

    Stryker is recalling 2,577 Duracon Tibial Wedge implants because they punctured the packaging's Tyvek lids, potentially compromising sterility.

    Product
    Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2016·2015-11-25

    Stryker Recalls PCA Acetabular Inserts Due to Regulatory Omission

    Stryker Howmedica Osteonics Corp. is recalling six PCA 10 Degree Hooded Acetabular Inserts because the 22 mm size was inadvertently omitted from the FDA 510(k) clearance.

    Product
    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0261-2016·2015-11-18

    Stryker Vitallium Femoral Heads Recalled Due to Assembly Failure

    Stryker Howmedica Osteonics Corp. is recalling 201 Vitallium femoral heads because they could not be assembled with their corresponding stems during surgery.

    Product
    Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2016·2015-11-18

    Stryker Recalls Triathlon MIS Modular Distal Capture Instruments

    Stryker is recalling specific lots of Triathlon MIS Modular Distal Capture instruments because they may disassociate during use.

    Product
    Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2810-2015·2015-09-30

    Stryker Recalls Trident Hip Implant Components Due to Documentation Error

    Stryker Howmedica Osteonics is recalling 16 units of Trident hip implant inserts due to a documentation issue, despite the parts meeting all device specifications.

    Product
    Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2429-2015·2015-08-26

    Stryker Recalls Wrist Implants Due to Potential Sterile Barrier Compromise

    Stryker is recalling specific wrist implant models because their sterile packaging may be compromised during transportation.

    Product
    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2428-2015·2015-08-26

    Stryker Recalls Radio-Capitellum Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific Radio-Capitellum implants because transportation may have compromised the sterile barrier of the packaging.

    Product
    Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2430-2015·2015-08-26

    Stryker Recalls Sigmoid Notch Radial Plates Due to Packaging Integrity Concerns

    Stryker is recalling Sigmoid Notch Radial Plates because the sterile packaging barrier may be compromised during transportation.

    Product
    Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2389-2015·2015-08-26

    Stryker Triathlon X3 Tibial Bearing Insert Recall Due to Labeling Error

    Stryker is recalling 10 units of Triathlon X3 Tibial Bearing Inserts because one unit was found in a pack labeled for a different model.

    Product
    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2426-2015·2015-08-26

    Stryker Recalls rHead and uHead Implants Due to Packaging Integrity Concerns

    Stryker Howmedica Osteonics Corp. is recalling specific rHead, uHead, and other radial implants because their sterile packaging may be compromised by transportation.

    Product
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2427-2015·2015-08-26

    Stryker Recalls uHead and Other Ulnar Implants Due to Packaging Concerns

    Stryker is recalling specific ulnar implants because the sterile packaging may be compromised by transportation.

    Product
    uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2360-2015·2015-08-19

    Stryker Recalls Mislabelled Triathlon Tibial Inserts for Knee Replacement

    Stryker Howmedica Osteonics is recalling 26 Triathlon tibial inserts because one unit was found in a package labeled for a different catalog number.

    Product
    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2363-2015·2015-08-19

    Stryker Recalls Mispackaged Orthopedic Shoulder Trial Instruments

    Stryker is recalling 21 units of a shoulder trial instrument because the package contained the wrong part number.

    Product
    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. Howmedica Osteonics Corp. A Subsidiary of Stryker Corp. Stryker France Non-sterile Made in Cork Ireland
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1633-2015·2015-05-27

    Stryker Howmedica Hip Prosthesis Components Recalled for Seal Defects

    Stryker Howmedica is recalling 1,147 RESTORATION Acetabular Augment System components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1635-2015·2015-05-27

    Stryker Triathlon Femoral Component Recalled for Sterile Barrier Seal Issues

    Stryker Howmedica Osteonics is recalling 1,147 Triathlon femoral components because the inner blister seal strength may be below validated requirements, potentially affecting sterile shelf life.

    Product
    Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1634-2015·2015-05-27

    Stryker Scorpio femoral component recall due to blister seal strength

    Stryker Howmedica Osteonics is recalling 1,147 Scorpio femoral components because the inner blister peel strength may be below validated requirements, potentially affecting sterile barrier shelf life.

    Product
    Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2015·2015-05-20

    Stryker Recalls 80 mm Kinemax Stem Extenders Due to Mislabeling

    Stryker Howmedica Osteonics is recalling four 80 mm Kinemax Stem Extenders because they were shipped in boxes labeled for the 80 mm part but contained 40 mm extenders.

    Product
    Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2015·2015-03-25

    Stryker Recalls Triathlon Distal Capture Assembly Due to Weld Disassociation Risk

    Stryker Howmedica Osteonics is recalling 2,030 Triathlon Distal Capture Assemblies because a weld may disassociate, potentially causing the trigger mechanism to become loose or disassociated.

    Product
    Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
    Category
    Medical Device
    Distribution
    Distributed nationwide