Home / Companies / Howmedica Osteonics Corp.

Howmedica Osteonics Corp.

FDA Regulatory Profile

Summary

Total Recalls
229
510(k) Clearances
301
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0963-2026Class IIThe Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit boarNovember 12, 2025
Z-2640-2025Class II1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, ModAugust 28, 2025
Z-0023-2025Class IITriathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemenSeptember 4, 2024
Z-0044-2025Class IIMAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063August 7, 2024
Z-2732-2024Class IICustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); CatAugust 5, 2024
Z-2370-2024Class IIUNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplastyJune 19, 2024
Z-2371-2024Class IIUNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplastyJune 19, 2024
Z-2372-2024Class IIUNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplastyJune 19, 2024
Z-2153-2024Class IIGray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910May 23, 2024
Z-2152-2024Class IIHRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900May 23, 2024
Z-1624-2024Class IITRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip disFebruary 27, 2024
Z-1622-2024Class IITRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip disFebruary 27, 2024
Z-1630-2024Class IITRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip disFebruary 27, 2024
Z-1632-2024Class IITRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip disFebruary 27, 2024
Z-1623-2024Class IITRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip diFebruary 27, 2024
Z-1628-2024Class IITRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip diFebruary 27, 2024
Z-1629-2024Class IITRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip disFebruary 27, 2024
Z-1631-2024Class IITRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislFebruary 27, 2024
Z-1625-2024Class IITRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dFebruary 27, 2024
Z-1626-2024Class IITRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip diFebruary 27, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K193429Exeter V40 Femoral Stem, Exeter X3 RimFit CupAugust 13, 2020
K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate RetaMay 13, 2020
K130895REUNION RSA SHOULDER SYSTEMDecember 27, 2013
K123604ABG III MONOLITHIC HIP STEMAugust 16, 2013
K122015DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGEFebruary 22, 2013
K123166TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTFebruary 14, 2013
K122853NOVEL FIT AND FILL STEMFebruary 1, 2013
K121315STRYKER CMF MEDPOR CUSTOMIZED IMPLANTNovember 1, 2012
K121308HIP SYSTEMSJuly 30, 2012
K120578ACCOLADE II HIP STEMMarch 29, 2012
K113409S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAILFebruary 15, 2012
K112556ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTSSeptember 28, 2011
K110290EXETER HIP STEMSeptember 27, 2011
K103835REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) May 5, 2011
K101072TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITEApril 11, 2011
K102019RESTORATION ACETABULAR WEDGE AUGMENTSMarch 3, 2011
K103233MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERTFebruary 3, 2011
K102992T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREESDecember 22, 2010
K103104SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENTNovember 22, 2010
K100884STRYKER KNIFELIGHTJune 25, 2010