Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Orthopedic · 21 CFR 888.3358
Recent MDR events
89,781 adverse event reports on file
- G7 Dual Mobility Acetabular SystemJul 31, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02230
- G7 OSSEOTI ACETABULAR SHELLJul 31, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02231
- G7 Dual Mobility Acetabular SystemJul 31, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02232
- UNK CupJul 31, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02233
- UNK HeadJul 31, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02234
- Taperloc CompleteJul 31, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02236
- Taperloc CompleteJul 31, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02239
- Taperloc CompleteJul 31, 2026MalfunctionZimmer Biomet, Inc.0001825034-2026-02242
- M2A-MAGNUM MOD HD SZ 52MMJul 31, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02245
- M2A-MAGNUM 52-60MM TPR INS STDJul 31, 2026InjuryZimmer Biomet, Inc.0001825034-2026-02246
Event type breakdown
Recalls
297 recall events for this product code
- Encore Medical, LPOpen, ClassifiedFeb 2, 2026
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HX
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Z-1234-2026 · View FDA record ↗ - Zimmer, Inc.Open, ClassifiedNov 3, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constraine
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Z-0418-2026 · View FDA record ↗ - Zimmer, Inc.Open, ClassifiedNov 3, 2025
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constraine
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Z-0419-2026 · View FDA record ↗ - BioPro, Inc.Open, ClassifiedOct 14, 2025
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Z-0148-2026 · View FDA record ↗ - BioPro, Inc.Open, ClassifiedOct 14, 2025
BioPro Endo Head (Metal uni-polar, 38-55)
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Z-0149-2026 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedJul 21, 2025
Brand Name: EMPOWR Dual Mobility"
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Z-2147-2025 · View FDA record ↗ - Encore Medical, LPOpen, ClassifiedJul 21, 2025
Brand Name: EMPOWR Dual Mobility"
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Z-2148-2025 · View FDA record ↗ - Conformis Inc.Open, ClassifiedApr 15, 2025
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Z-1569-2025 · View FDA record ↗ - Exactech, Inc.Open, ClassifiedFeb 12, 2025
Alteon XLE
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
Z-1167-2025 · View FDA record ↗ - Novosource, LLCOpen, ClassifiedNov 18, 2024
NovoHip Biolox Ball Head 32mmL
Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
Z-0483-2025 · View FDA record ↗
Registered firms
2,850 firms currently registered for this product code
Sct, Inc.
FRANKLIN LAKES, NJ, US
Zimmer Biomet Canada Dfe
Mississauga Ontario, CA
Ceramtec Gmbh Medical Products Division
PLOCHINGEN Baden-Wurttemberg, DE
Zimmer, Inc.
WARSAW, IN, US
Limacorporate S.p.a.
Calatafimi Segesta (TP) Sicilia, IT
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Smith & Nephew, Inc.
MEMPHIS, TN, US
United Orthopedic Corp.
Kaohsiung, TW
Sterigenics Us, Llc
Lewis Center, OH, US
Orthoplastics Ltd
Bacup Lancashire, GB
Zimmer Biomet Korea Ltd.
Seoul, KR
Isomedix Operations Inc.
Sandy, UT, US
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Uoc Usa Inc.
Irvine, CA, US
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Orchid Orthopedics-chelsea
Chelsea, MI, US
Exactech, Inc.
GAINESVILLE, FL, US
Arch Medical Solutions - Memphis
Lexington, TN, US
Valtecne Spa
Berbenno di Valtellina Sondrio, IT
Isomedix Operations Inc.
Northborough, MA, US
Cpm Medical Consultants, Llc.
Farmers Branch, TX, US
Flex-cell Precision, Inc.
Lancaster, PA, US
510(k) clearances
563 clearances for this product code
- Globus Medical, Inc.Aug 4, 2026
K254043 · TRIVANCE Hip Stem
- Howmedica Osteonics Corp., Dba Stryker OrthopaedicsJul 10, 2026
K261624 · Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component
- Nextstep Arthopedix, LLCJun 5, 2026
K243192 · iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating
- Biomet, Inc.May 19, 2026
K251270 · Taperloc® Complete Hip Stem
- Zimmer, Inc.Feb 4, 2026
K252623 · G7® Revision Acetabular System
- Medacta International S.A.Jan 28, 2026
K251043 · Mpact 3D Metal Implants Extension DMLS Technology
- Restor3D, Inc.Dec 5, 2025
K252067 · Velora Acetabular System
- Shalby Advanced Technologies, Inc. Dba Consensus OrthopedicsNov 20, 2025
K252846 · TaperSet Hip System