Howmedica Osteonics Corp.
Howmedica Osteonics Corp. holds FDA 510(k) medical device clearances, first cleared 1999, most recent 2020, with 248 FDA device recalls on record.
Top product codes for Howmedica Osteonics Corp.
FDA recalls by Howmedica Osteonics Corp.
10 most recent of 248- Z-0164-2027 — TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
- Z-0166-2027 — Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
- Z-0165-2027 — TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
- Z-0167-2027 — TS Misc. Instruments Tray, Triathlon. Catalog Number: 6543-6-519.
- Z-3206-2026 — SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Z-3199-2026 — ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW C-M110-1-201 BUSHING AND BEARING USE C-MM100253-00 C-MM100253-02 DURACON TIB INSERT LG 12MM MED 14MM LAT C-M066-3-000 EXETER WINGLESS CENTRALISER FOR C-M082-7-302 C-M082-7-303 EXETER WINGLESS CENTRALIZER XSM C-M107-5-301 GMRS EXTRA SM ALL-POLY TIBIA SIZE 11mm C-MM100616-02 GMRS EXTRA SM ALL-POLY TIBIA SIZE 16mm C-MM100616-03 GMRS EXTRA SM ALL-POLY TIBIA SIZE 8mm C-MM100616-01 GMRS SML POLY TIBIA 11MM CASE 100520 C-MM100520-03 GMRS SML POLY TIBIA 16MM CASE 100520 C-MM100520-04 GMRS SML POLY TIBIA 8MM CASE 100520 C-MM100520-02 GMRS SML TIBIA 11MM WITH CASE 100411 C-MM100411-03 GMRS SML TIBIA 14MM WITH CASE 100411 C-MM100411-04 GMRS SML TIBIA 8MM WITH CASE 100411 C-MM100411-02 GMRS TIB INSRT SML 10MM WITH CASE 100507 C-MM100507-04 GMRS TIB INSRT SML 16MM WITH CASE 100507 C-MM100507-06 KALI TIBIAL INSERT LARGE RIGHT 8mm C-M071-6-601 KRH REV TIB INS 16mm THK .655 DIA STEM C-M113-5-603 MRH KNEE TIBIAL INSERT FOR THIN POST C-M067-3-103 MRS RADIAL BUSHING FORITH C-M107-7-800 C-M107-7-801 SELF-PRESSURIZING GLENOID SIZE 9 C-M064-4-300 TRIATHLON NO. 9 TIBIAL INSERT 11MM C-M067-5-003 TRIATHLON NO. 9 TIBIAL INSERT 9MM C-M067-5-002 TRIDENT ALL POLY CUP 44 X 66MM C-M066-0-901 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE A X 22mm ID UH1 C-M104-2-002 TRIDENT CONSTRAINED ACETABULAR INSERT SIZE B X 22mm ID UH1 C-M104-2-003 UHR BIPOLAR 22X38MM UH1-38-22 UHR BIPOLAR 22X40MM UH1-40-22 UHR BIPOLAR 22X41MM UH1-41-22 UHR BIPOLAR 22X42MM UH1-42-22 UHR BIPOLAR 22X43MM UH1-43-22 UHR BIPOLAR 22X45MM UH1-45-22 UHR BIPOLAR 26X41mm UH1-41-26 UHR BIPOLAR 26X42mm UH1-42-26 UHR BIPOLAR 26X43mm UH1-43-26 UHR BIPOLAR 26X44mm UH1-44-26 UHR BIPOLAR 26X45mm UH1-45-26 UHR BIPOLAR 26X46mm UH1-46-26 UHR BIPOLAR 26X47mm UH1-47-26 UHR BIPOLAR 26X48mm UH1-48-26 UHR BIPOLAR 28X42mm UH1-42-28 UHR BIPOLAR 28X44mm UH1-44-28 UHR BIPOLAR 28X45mm UH1-45-28 UHR BIPOLAR 28X46mm UH1-46-28 UHR BIPOLAR 28X47mm UH1-47-28 UHR BIPOLAR 28X48mm UH1-48-28 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Z-3201-2026 — ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852 CONSTRAINED ACETABULAR INSERTS 22MM 50MM 2099-2250 CONSTRAINED ACETABULAR INSERTS 22MM 52MM 2099-2252 CONSTRAINED ACETABULAR INSERTS 22MM 56MM 2099-2256 CONSTRAINED ACETABULAR INSERTS 28MM 61MM 2099-2861 EIUS UNI TIB SMALL RM/LL 9MM 6636-0-419 PCA CONST LINER 32MM NEUTRAL C - SHELL 6299-N-332 SYS 12 CONST LINER 32ID 10 DEG P6 +4MM 6302-H-632 TRIDENT 0 DEG CONSTRAINED INSERT 22D 690-00-22D TRIDENT 0 DEG CONSTRAINED INSERT 22E 690-00-22E TRIDENT 0 DEG CONSTRAINED INSERT 28F 690-00-28F TRIDENT 0 DEG CONSTRAINED INSERT 28G 690-00-28G TRIDENT 0 DEG CONSTRAINED INSERT 32I 690-00-32I TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D TRIDENT CONSTR ACET INSERT 690-10-28K TRIDENT CONSTRAINED INSERT 690-10-22E 690-10-22F 690-10-28G 690-10-28H 690-10-28I Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Z-3196-2026 — OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Z-3204-2026 — TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Z-3197-2026 — ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA 73-0110 73-0710 73-0910 SCORPIO RECESSED PATELLA 26MM 3044-0026 SCORPIO TS TIB INS 72-4-9114 SCORPIO TS TIBIAL INSERT 72-4-0324 SCORPIOFLEX TOTAL KNEE CR 72-16-0512 72-16-0518 72-16-0912 72-16-1112 SERIES II TIBIAL BEAR INSERT NO 11 15MM 3052-1115 UHR BIPOLAR 26X52mm UH1-52-26 UHR BIPOLAR 26X58mm UH1-58-26 UHR BIPOLAR 28X48mm UH1-48-28 UHR BIPOLAR 28X52mm UH1-52-28 UHR BIPOLAR 28X55mm UH1-55-28 UHR BIPOLAR 32X49MM UH1-49-32 UHR BIPOLAR 32X51MM UH1-51-32 UHR BIPOLAR 32X52MM UH1-52-32 UHR BIPOLAR 32X54MM UH1-54-32 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
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.