Zimmer Gmbh
FDA adverse event reports naming Zimmer Gmbh as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ZIMMER GMBH.
- Total reports
- 15,153
- Deaths
- 35
- Injuries
- 11,571
- Malfunctions
- 1,012
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA7,472
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO2,727
- Prosthesis, Hip, Hemi-, Acetabular, Cemented, MetalKWB755
- Rod, Fixation, Intramedullary And AccessoriesHSB738
- Plate, Fixation, BoneHRS630
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI611
- Posterior Metal/Polymer Spinal System, FusionNQP295
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY292
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS262
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH139
Recent recalls
- 2024-09-12Open, ClassifiedUnder Investigation by firm
Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
- 2024-09-12Open, ClassifiedUnder Investigation by firm
Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
- TerminatedProcess control
Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.
Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .
- TerminatedUnder Investigation by firm
Normed Charcot Osteotome Chisel (Various sizes)
Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
- TerminatedUnder Investigation by firm
Drill Sys 2.7, 2x105mm, stryker, Item Number 502015106
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- TerminatedUnder Investigation by firm
Drill Sys2.7, 2x103mm, AO, Item Number 502015107
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- TerminatedUnder Investigation by firm
Drill, 15mm stop, 1x83mm, Stryker, Item Number 502015114
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- TerminatedUnder Investigation by firm
Drill, 15mm stop, 1x76mm, AO , Item Number 502015115
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- TerminatedUnder Investigation by firm
Drill, 26mm stop, 1.4x94mm, Stryker, Item Number 502015120
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
- TerminatedUnder Investigation by firm
Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
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