Howmedica Osteonics Corp.
158 recalls on record · Latest: Dec 31, 2025
FDA Devices Moderate Feb 7, 2024
HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
FDA Devices Moderate Feb 7, 2024
P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107
FDA Devices Moderate Feb 7, 2024
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
FDA Devices Moderate Feb 7, 2024
SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
FDA Devices Moderate Feb 7, 2024
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
FDA Devices Moderate Feb 7, 2024
LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228
FDA Devices Moderate Feb 7, 2024
Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324
FDA Devices Moderate Feb 7, 2024
LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
FDA Devices Moderate Feb 7, 2024
P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
FDA Devices Moderate Feb 7, 2024
SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110
FDA Devices Moderate Feb 7, 2024
DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
FDA Devices Moderate Feb 7, 2024
SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
FDA Devices Moderate Feb 7, 2024
SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
FDA Devices Moderate Feb 7, 2024
RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
FDA Devices Moderate Jun 7, 2023
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
FDA Devices Moderate Jun 7, 2023
TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
FDA Devices Moderate Apr 19, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Devices Low Dec 28, 2022
Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
FDA Devices Low Dec 28, 2022
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
FDA Devices Moderate Nov 23, 2022
Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
FDA Devices Moderate Oct 5, 2022
Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
FDA Devices Moderate Jun 15, 2022
Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon¿ Tritanium¿ Tibial Component (Size 5); Catalog Number 5536-B-500
FDA Devices Moderate Apr 6, 2022
Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
FDA Devices Moderate Feb 23, 2022
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
FDA Devices Moderate Jan 12, 2022
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instrument…
FDA Devices Moderate Dec 8, 2021
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
FDA Devices Moderate Dec 8, 2021
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
FDA Devices Moderate Apr 14, 2021
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-cons…
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
FDA Devices Moderate May 27, 2020
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Right, Sterile, Catalog # 504-02-58D-R, UDI (01)07613327012446(17)
FDA Devices Moderate Oct 9, 2019
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 RIGHT Catalog # 5542-A-202 - Product Usage: Triathlon Femoral Distal Augments are used with Triathlon…
FDA Devices Moderate Oct 9, 2019
TRIATHLON FEMORAL DISTAL AUGMENT 15MM - SIZE 2 LEFTTriathlon Femoral Distal Augments are used with Triathlon TS Femoral Components during revision To…
FDA Devices Moderate Aug 14, 2019
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
FDA Devices Moderate Jan 2, 2019
HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE
FDA Devices Moderate Dec 26, 2018
Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retracti…
FDA Devices Moderate Dec 19, 2018
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF su…
FDA Devices Moderate Nov 14, 2018
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Jo…
FDA Devices Moderate Oct 31, 2018
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is …
FDA Devices Moderate Aug 15, 2018
radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and U…
FDA Devices Moderate Aug 15, 2018