Howmedica Osteonics Corp.
Howmedica Osteonics Corp. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2020, with 232 FDA device recalls on record.
Top product codes for Howmedica Osteonics Corp.
FDA recalls by Howmedica Osteonics Corp.
10 most recent of 232- Z-2461-2026 — TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
- Z-2462-2026 — TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
- Z-1572-2026 — MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
- Z-0963-2026 — The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
- Z-2640-2025 — 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
- Z-0023-2025 — Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
- Z-0044-2025 — MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- Z-2732-2024 — Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
- Z-2370-2024 — UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
- Z-2371-2024 — UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Howmedica Osteonics Corp.
1–100 of 288- K193429 — Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
- K200782 — Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
- K130895 — REUNION RSA SHOULDER SYSTEM
- K123604 — ABG III MONOLITHIC HIP STEM
- K122015 — DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
- K123166 — TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P
- K122853 — NOVEL FIT AND FILL STEM
- K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
- K121308 — HIP SYSTEMS
- K113409 — S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
- K112556 — ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
- K110290 — EXETER HIP STEM
- K103835 — REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) REUNION TSA SYSTEM N
- K101072 — TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
- K103233 — MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
- K102992 — T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
- K103104 — SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
- K100884 — STRYKER KNIFELIGHT
- K101438 — T2 GREATER TROCHANTER NAIL
- K100271 — VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
- K101056 — VARIAX ELBOW SYSTEM
- K100475 — AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
- K091955 — STRYKER SONICPIN SYSTEM
- K093433 — VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
- K093644 — RESTORATION ADM SYSTEM X3 ACETABULAR
- K092178 — AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS
- K092406 — ABG II MODULAR HIP STEM
- K090897 — TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT
- K092561 — REJUVENATE MODULAR STEM
- K092834 — HOFFMAN XPRESS LINE EXTENSION
- K092671 — VARIAX ELBOW SYSTEM LINE EXTENSION
- K092419 — AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
- K091161 — REJUVENATE MONOLITHIC SIZE 4 HIP STEM
- K082892 — REJUVENATE MONOLITHIC HIP SYSTEM
- K083437 — MODIFICATION TO T2 RECON NAIL SYSTEM
- K082018 — T2 FLEXIBLE NAIL
- K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
- K081171 — TRITANIUM ACETABULAR SHELL SYSTEM
- K081284 — VARIAX DISTAL FIBULA PLATE
- K081152 — T2 FEMORAL NAIL
- K081044 — REJUVENATE MODULAR HIP SYSTEM
- K081278 — OMEGA 3 TROCHANTERIC STABILIZING PLATE
- K080667 — VARIAX DISTAL RADIUS TORX SCREWS
- K073076 — HOFFMANN LIGHT SYSTEM
- K073527 — VARIAX ELBOW SYSTEM
- K072020 — RESTORATION ADM SYSTEM
- K072221 — MODIFICATION TO TRIATHLON TS KNEE SYSTEM
- K071881 — TRIATHLON PKR SYSTEM
- K071082 — STRYKER MODULAR HIP SYSTEM
- K071471 — CORIN ADAPTOR SLEEVE
- K071991 — MODIFICATION TO SCORPIO NRG KNEE SYSTEM
- K070095 — TRIATHLON TS KNEE SYSTEM
- K070885 — UNIVERSAL TAPER DELTA FEMORAL HEAD
- K070883 — DURACON X3 CS TIBIAL INSERT
- K071092 — ASNIS MICRO CANNULATED SCREW
- K070963 — REUNION HA FRACTURE STEM
- K070454 — OMEGA 3 SUPRACONDYLAR PLATE
- K063875 — STRYKER FOOT PLATING SYSTEM
- K063445 — PCA CONSTRAINED ACETABULAR LINERS
- K063550 — SYSTEM 12 CONSTRAINED ACETABULAR LINERS
- K063552 — SERIES II CONSTRAINED ACETABULAR LINERS
- K063857 — SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
- K063225 — METAIZEAU NAILING SYSTEM
- K063616 — TRIDENT II ACETABULAR SYSTEM
- K062845 — MODULAR REPLACEMENT ELBOW SYSTEM
- K062419 — TRIDENT LARGE DIAMETER ACETABULAR INSERTS
- K062498 — PROFYLE SYSTEM
- K062113 — SOLAR REUNION FRACTURE STEM
- K061434 — TRIDENT LARGE DIAMETER HIP SYSTEM
- K062066 — OMEGA 3 SYSTEM
- K061521 — TRIATHLON METAL BACKED PATELLA
- K053348 — STRYKER ORTHOPAEDICS RFID INSTRUMENTATION
- K062037 — TRIATHLON LOW PROFILE TIBIAL TRAY
- K061168 — PCA 36MM FEMORAL HEADS
- K061677 — SOLAR PUREFIX HA SHOULDER
- K061654 — TRIDENT CONSTRAINED ACETABULAR INSERT
- K061012 — AXSOS PLUS LOCKING PLATE SYSTEM
- K060613 — VARIAX LOCKING PLATE SYSTEM
- K060921 — S2 RECON NAIL SYSTEM
- K060798 — STRYKER PLATING SYSTEM
- K060514 — STRYKER PLATING SYSTEM
- K060360 — HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
- K053198 — SIMPLEX P SPEEDSET BONE CEMENT
- K053472 — HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
- K052917 — STRYKER COMPARTMENTAL KNEE SYSTEM
- K053349 — HOFFMANN II ROD TO WIRE COUPLING
- K052748 — SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
- K053038 — HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM
- K052718 — V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
- K051948 — AVON PATELLO-FEMORAL JOINT PROSTHESIS
- K051977 — SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
- K051380 — TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
- K052037 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K051590 — T2 ANKLE ARTHRODESIS NAIL
- K051737 — MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
- K051738 — SECUR-FIT MAX AND PLUS MAX HIP STEMS
- K051146 — TRIATHLON KNEE SYSTEM
- K051588 — BIOLOX DELTA CERAMIC FEMORAL HEADS
- K051624 — T2 RECON NAIL SYSTEM
- K051363 — RESTORATION MODULAR SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.