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.

1–25 of 87

HighFDA (Devices)·Z-2160-2017·2017-05-31
Stryker Recalls Hoffmann LRF Safety Clips Due to Loosening Risk
Stryker is recalling Hoffmann LRF Safety Clips because they may loosen from the Quick Release mechanism on Transport Struts.
Product
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1020-2017·2017-01-18
Stryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
Stryker Howmedica Osteonics Corp. is recalling 131 units of the Reunion TSA Peg Alignment Sound because the instrument broke during surgery.
Product
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to fi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0880-2017·2016-12-28
Stryker Recalls Kirschner Wires Due to Potential Sterile Pouch Seal Failure
Stryker Howmedica Osteonics Corp. is recalling specific lots of GAM Kirschner Wires and T2 K-Wires because a manufacturing error may have compromised the sterile pouch seal.
Product
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0378-2017·2016-11-16
Stryker Recalls LFIT Anatomic V40 Femoral Heads Due to Taper Lock Failure
Stryker Howmedica Osteonics is recalling specific lots of LFIT Anatomic V40 Femoral Heads because of reported taper lock failures that caused harm.
Product
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0060-2017·2016-10-19
Stryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
Stryker Howmedica Osteonics Corp. is recalling 3,768 units of the Universal Acetabular Cup Positioner/Impactor because the thread length may protrude past the dome of the acetabular trial or implant.
Product
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2789-2016·2016-09-21
Stryker Patella Assembly Instrument Recalled for Component Disassociation Risk
Stryker Howmedica Osteonics is recalling 2,039 units of the Scorpio Patella Assembly Instrument because press-fit failures could cause clamping components and pins to disassociate.
Product
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2792-2016·2016-09-21
Stryker Recalls Mislabelled Femoral and Tibial Nails
Stryker Howmedica Osteonics Corp. is recalling specific femoral and tibial nails that were incorrectly labeled and distributed to California.
Product
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and corr
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2791-2016·2016-09-21
Stryker Recalls Mislabelled T2 Supracondylar Nail System
Stryker Howmedica Osteonics Corp. is recalling one unit of the T2 Supracondylar Nail System because it was incorrectly labeled and distributed.
Product
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Patholo
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2390-2016·2016-08-17
Stryker Triathlon Tibial Alignment Handle Recalled Due to Weld Defect
Stryker Howmedica Osteonics is recalling 47 units of the Specialty Triathlon Tibial Alignment Handle because the secondary locking mechanism may disassociate during surgery due to a weld defect.
Product
Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2377-2016·2016-08-17
Stryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues
Stryker Howmedica Osteonics is voluntarily recalling Triathlon Modular Handle instruments because press fit specifications were not met, potentially causing disassociation.
Product
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replace
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2396-2016·2016-08-17
Stryker Recalls Exeter Rasp Handle Due to Malfunctioning
Stryker Howmedica Osteonics Corp. is recalling 241 Exeter Rasp Handles because they may malfunction during use.
Product
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2016·2016-08-03
Stryker Trident Constrained Liner Inserter Impactor Tip Recall
Stryker is recalling Trident Constrained Liner Inserter Impactor Tips because they do not meet required sterility assurance levels when steam sterilized.
Product
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1507-2016·2016-04-27
Stryker Recalls VariAx Compression Plating System Due to Screw Failure
Stryker Howmedica Osteonics Corp. is recalling 118 units of the VariAx Compression Plating System because bone screws may pass through oblong holes during insertion.
Product
VariAx Compression Plating System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0867-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0868-2016·2016-03-02
Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns
Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0883-2016·2016-03-02
Stryker T2 K-Wire Recall 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, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0872-2016·2016-03-02
Stryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma3 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0871-2016·2016-03-02
Stryker Gamma Guide Pin Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0869-2016·2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 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-0855-2016·2016-03-02
Stryker Vitallium Wire Recalled Due to Sterilization Labeling Error
Stryker is recalling Vitallium Wire because the instructions incorrectly state the non-sterile device is sterile, omitting required sterilization steps.
Product
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
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-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-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-0874-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterility of the medical devices.
Product
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide