Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Orthopedic · 21 CFR 888.3690
Recent MDR events
10,195 adverse event reports on file
- UNK Shoulder MetagleneJul 31, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13114
- DELTA XTENDJul 30, 2026MalfunctionDepuy Ireland - 96166711818910-2026-12985
- DELTA XTENDJul 30, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-13057
- GLOBAL UNITEJul 29, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12926
- GLOBAL UNITEJul 29, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12927
- GLOBAL UNITEJul 28, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12881
- DELTA XTENDJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12546
- DELTA XTENDJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12547
- DELTA XTENDJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12549
- DELTA XTENDJul 27, 2026InjuryDepuy Orthopaedics Inc Us1818910-2026-12550
Event type breakdown
Recalls
19 recall events for this product code
- Limacorporate S.p.ATerminatedSep 2, 2015
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder im
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Z-2540-2015 · View FDA record ↗ - Arthrosurface, Inc.TerminatedFeb 12, 2015
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Hum
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Z-1110-2015 · View FDA record ↗ - Arthrosurface, Inc.TerminatedFeb 12, 2015
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Hu
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Z-1111-2015 · View FDA record ↗ - Arthrosurface, Inc.TerminatedFeb 12, 2015
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humer
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Z-1112-2015 · View FDA record ↗ - Arthrosurface, Inc.TerminatedFeb 12, 2015
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Hume
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Z-1113-2015 · View FDA record ↗ - Arthrosurface, Inc.TerminatedFeb 12, 2015
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
Z-1114-2015 · View FDA record ↗ - Zimmer, Inc.TerminatedJul 10, 2013
Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm
The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
Z-1676-2013 · View FDA record ↗ - Synvasive Technology IncTerminatedApr 17, 2013
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Z-1127-2013 · View FDA record ↗ - Zimmer Inc.TerminatedNov 12, 2009
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13.
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
Z-0177-2010 · View FDA record ↗ - Zimmer Inc.TerminatedNov 12, 2009
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13.
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
Z-0178-2010 · View FDA record ↗
Registered firms
1,182 firms currently registered for this product code
Zimmer Pte. Ltd.
Singapore South East, SG
Arthrex Distribution Hub Emea B.v.
Venlo Limburg, NL
Depuy (ireland)
CO. CORK Munster, IE
Mid South Precision
Murfreesboro, TN, US
Oeb S.r.l.
Camposanto Modena, IT
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Complexus Medical
Mishawaka, IN, US
Exactech, Inc.
GAINESVILLE, FL, US
Smith & Nephew, Inc.
MEMPHIS, TN, US
Ionisos
Dagneux Ain, FR
Catalyst Orthoscience Inc
Naples, FL, US
Eddi Bressan S.r.l.
CORMONS Gorizia, IT
Gb Implantat Technologie Gmbh
Bochum North Rhine-Westphalia, DE
Rms Surgical
Anoka, MN, US
Lh Medical Corporation
Fort Wayne, IN, US
Bbf Sterilisationsservice Gmbh
Kernen Baden-Wurttemberg, DE
Tornier S.a.s.
Montbonnot Saint-Martin Isere, FR
Changzhou Biomet Medical Devices Co., Ltd.
Changzhou City Jiangsu, CN
Isomedix Operations, Inc.
Libertyville, IL, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Zimmer Biomet Korea Ltd.
Seoul, KR
Shoulder Innovations, Inc
Grand Rapids, MI, US
Arthrex Logistic Center
Fort Myers, FL, US
510(k) clearances
71 clearances for this product code
- Arthrex, Inc.Feb 12, 2024
K233260 · Univers Revers CA Head and Adapter
- Arthrex, Inc.May 19, 2022
K221232 · Univers Revers Humeral Cup Implant
- Implantcast GmbHNov 12, 2020
K191433 · AGILON® XO Shoulder Replacement System
- Biocore9, LLCMay 15, 2020
K193122 · Biocore9 Humeral Resurfacing System
- Arthrosurface, Inc.Apr 18, 2018
K173964 · OVOMotion Shoulder Arthroplasty System
- Arthrex, Inc.Nov 21, 2016
K161782 · Arthrex Univers Revers Shoulder Prosthesis System
- Zimmer GmbHNov 1, 2016
K161620 · Anatomical Shoulder Domelock Dome centric
- Arthrex, Inc.Apr 19, 2016
K151527 · Arthrex Univers Revers CA Heads and Adapters