Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous Cemented, Osteophilic Finish
Orthopedic · 21 CFR 888.3353
Recent MDR events
499 adverse event reports on file
- RINGLOC HIP SYSTEMMay 20, 2026InjuryZimmer Biomet, Inc.0001825034-2026-01415
- EXACTECH STEMJan 22, 2026MalfunctionExactech, Inc.MW5182651
- ZIMMER BIOMET 28 MM DIAMETER HEAD CUP LINER 28 MMDec 5, 2025InjuryZimmer, Inc.MW5180027
- E-POLY 36MM +3 HIWALL LNR SZ23Jan 6, 2025InjuryZimmer Biomet, Inc.0001825034-2025-00034
- IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MMNov 23, 2024MalfunctionStryker Gmbh0009610622-2024-00925
- IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.0X400MMOct 30, 2024MalfunctionStryker Gmbh0009610622-2024-00897
- IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MMOct 30, 2024MalfunctionStryker Gmbh0009610622-2024-00898
- DA VINCISep 26, 2024InjuryIntuitive Surgical, Inc2955842-2024-19823
- IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.5X400MMSep 10, 2024MalfunctionStryker Gmbh0009610622-2024-00832
- IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MMAug 13, 2024MalfunctionStryker Gmbh0009610622-2024-00790
Event type breakdown
Recalls
19 recall events for this product code
- Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0867-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, Gamma K-Wire 3.2x450 mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0869-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, Gamma Guide Pin, 4x400 mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0871-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0872-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 K-Wire, 3x285 mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0873-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0874-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0875-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0876-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0877-2016 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 25, 2016
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm
During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.
Z-0878-2016 · View FDA record ↗
Registered firms
231 firms currently registered for this product code
Isomedix Operations Inc.
Northborough, MA, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Zimmer Gmbh
WINTERTHUR Zurich, CH
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Howmedica Osteonics Corp
MAHWAH, NJ, US
Biomet Mexico
Mexico City Ciudad de Mexico, MX
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Biomet, Inc.
WARSAW, IN, US
Lh Medical Corporation
Fort Wayne, IN, US
T & L Sharpening, Inc.
Indiana Beach, IN, US
Single Source Medical Llc
Churubusco, IN, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Zimmer Biomet Canada Dfe
Mississauga Ontario, CA
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Almark Tool & Manufacturing Company, Inc.
Garwood, NJ, US
510(k) clearances
4 clearances for this product code
- Howmedica Osteonics Corp.Aug 16, 2013
K123604 · ABG III MONOLITHIC HIP STEM
- Stryker Corp.May 25, 2011
K110807 · ABG II MONOLITHIC HIP STEM
- Biomet, Inc.Feb 11, 2009
K090103 · 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL
- Portland Orthopaedics Pty. , Ltd.Oct 7, 2005
K051844 · EQUATOR PLUS ACETABULAR CUP SYSTEM