Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Orthopedic · 21 CFR 888.3353
Recent MDR events
10,185 adverse event reports on file
- ACTISJul 31, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13080
- ACTISJul 31, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13110
- ACTISJul 30, 2026InjuryDepuy Ireland - 96166711818910-2026-13003
- CORAILJul 30, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13043
- CORAILJul 29, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12909
- ACTISJul 29, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12928
- ACTISJul 28, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12817
- ACTISJul 27, 2026InjuryDepuy Ireland - 30155162661818910-2026-12584
- ACTISJul 27, 2026MalfunctionDepuy Orthopaedics Inc Us1818910-2026-12754
- ACTISJul 22, 2026InjuryDepuy Ireland - 30155162661818910-2026-12495
Event type breakdown
Recalls
196 recall events for this product code
- Theken Companies LLCOpen, ClassifiedOct 21, 2025
iNSitu Bipolar Hip System, Bipolar head implant
Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Z-0227-2026 · View FDA record ↗ - Biomet, Inc.TerminatedDec 17, 2020
RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Por
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Z-0628-2021 · View FDA record ↗ - Exactech, Inc.TerminatedJan 18, 2018
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5
Wrong device description of the label identifying the implant
Z-0538-2018 · View FDA record ↗ - Depuy Orthopaedics Inc.TerminatedNov 21, 2016
ACTIS Flex Reamers SZ 0/1; 2/3; 4/5; 6/7; 8/9; 10/11; 12, Product is sold non-sterile, these instruments are packed non-sterile, within a rigid tube with foam p
DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.
Z-0650-2017 · View FDA record ↗ - Smith & Nephew, Inc.TerminatedJul 28, 2016
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Z-2297-2016 · View FDA record ↗ - Exactech, Inc.TerminatedNov 2, 2015
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Z-0201-2016 · View FDA record ↗ - Zimmer GmbhTerminatedFeb 20, 2015
CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damag
Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.
Z-1135-2105 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedFeb 3, 2015
Trident PSL HA Solid Back 50 mm
Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
Z-1043-2015 · View FDA record ↗ - Stryker Howmedica Osteonics Corp.TerminatedApr 2, 2014
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #62
Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.
Z-1317-2014 · View FDA record ↗ - Medacta Usa IncTerminatedFeb 23, 2013
Versafitcup Impacting Ring
Medacta USA is recalling Versafitcup Impacting Ring because the impaction ring may not fit properly in the implant shell in all cases. This could result in surgical delay potentially increasing possible complications under anesthesia, having to ream up to a larger shell size leaving less bone than planned and repositiong/removal of the shell after initial impaction.
Z-0878-2013 · View FDA record ↗
Registered firms
1,346 firms currently registered for this product code
Zimmer Biomet Canada Dfe
Mississauga Ontario, CA
Ceramtec Gmbh Medical Products Division
PLOCHINGEN Baden-Wurttemberg, DE
Exactech, Inc.
GAINESVILLE, FL, US
Zimmer, Inc.
WARSAW, IN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Sterigenics Us Llc
West Memphis, AR, US
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Orchid Orthopedics-chelsea
Chelsea, MI, US
Arch Medical Solutions - Memphis
Lexington, TN, US
Applimed Sa -cssr
Châtel St Denis Fribourg, CH
Isomedix Operations Inc.
Northborough, MA, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Aps Materials Inc. Ireland
Waterford, IE
Millstone Medical Outsourcing Llc.
FALL RIVER, MA, US
Corin Limited
CIRENCESTER Gloucestershire, GB
United Orthopedic Corp.
Kaohsiung, TW
Dot America, Inc.
Columbia City, IN, US
Uoc Usa Inc.
Irvine, CA, US
Gmed Healthcare Bvba ( A Johnson & Johnson Company)
Courcelles Luxembourg, BE
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Howmedica Osteonics Corp
MAHWAH, NJ, US
510(k) clearances
159 clearances for this product code
- Waldemar Link GmbH & Co. KGNov 5, 2025
K250375 · Allure Hip Stem and Intramedullary Plugs
- Medacta International S.A.Jun 13, 2025
K251166 · Mfinity Femoral System
- Ortho Development Corp.May 22, 2025
K251052 · Trivicta® Hip Stem
- United Orthopedic CorporationMay 1, 2025
K242315 · Resolve Modular Revision Hip Stem
- Exactech, Inc.Mar 10, 2025
K243839 · Alteon® HA Femoral Stems
- Signature Orthopaedics Pty, Ltd.Nov 25, 2024
K243162 · World Liner
- Corin U.S.A. LimitedOct 3, 2024
K241472 · Icona Hip Stem
- Nextstep ArthropedixSep 13, 2024
K241875 · TheRay Collared and Collarless Femoral Stem