Howmedica Osteonics Corp.
FDA Regulatory Profile
Howmedica Osteonics Corp. appears in FDA public data with 232 recalls, 301 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2462-2026, Class II) was initiated on May 19, 2026. Its most recent 510(k) clearance was granted on August 13, 2020.
Summary
- Total Recalls
- 232
- 510(k) Clearances
- 301
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2462-2026 | Class II | TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. | May 19, 2026 |
| Z-2461-2026 | Class II | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | May 19, 2026 |
| Z-1572-2026 | Class II | MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | February 2, 2026 |
| Z-0963-2026 | Class II | The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit boar | November 12, 2025 |
| Z-2640-2025 | Class II | 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Mod | August 28, 2025 |
| Z-0023-2025 | Class II | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemen | September 4, 2024 |
| Z-0044-2025 | Class II | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | August 7, 2024 |
| Z-2732-2024 | Class II | Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Cat | August 5, 2024 |
| Z-2371-2024 | Class II | UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty | June 19, 2024 |
| Z-2370-2024 | Class II | UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty | June 19, 2024 |
| Z-2372-2024 | Class II | UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty | June 19, 2024 |
| Z-2152-2024 | Class II | HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900 | May 23, 2024 |
| Z-2153-2024 | Class II | Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910 | May 23, 2024 |
| Z-1625-2024 | Class II | TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip d | February 27, 2024 |
| Z-1621-2024 | Class II | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip d | February 27, 2024 |
| Z-1629-2024 | Class II | TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dis | February 27, 2024 |
| Z-1631-2024 | Class II | TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip disl | February 27, 2024 |
| Z-1622-2024 | Class II | TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dis | February 27, 2024 |
| Z-1632-2024 | Class II | TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dis | February 27, 2024 |
| Z-1626-2024 | Class II | TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip di | February 27, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | August 13, 2020 |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Reta | May 13, 2020 |
| K130895 | REUNION RSA SHOULDER SYSTEM | December 27, 2013 |
| K123604 | ABG III MONOLITHIC HIP STEM | August 16, 2013 |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE | February 22, 2013 |
| K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POST | February 14, 2013 |
| K122853 | NOVEL FIT AND FILL STEM | February 1, 2013 |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | November 1, 2012 |
| K121308 | HIP SYSTEMS | July 30, 2012 |
| K120578 | ACCOLADE II HIP STEM | March 29, 2012 |
| K113409 | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL | February 15, 2012 |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | September 28, 2011 |
| K110290 | EXETER HIP STEM | September 27, 2011 |
| K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C; XX=07-17,06L-12L) | May 5, 2011 |
| K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE | April 11, 2011 |
| K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS | March 3, 2011 |
| K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | February 3, 2011 |
| K102992 | T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES | December 22, 2010 |
| K103104 | SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT | November 22, 2010 |
| K100884 | STRYKER KNIFELIGHT | June 25, 2010 |