The Recall Desk

Manufacturer

Zimmer, Inc.

446 recalls in our database name Zimmer, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
446
Critical
0
Severe
44
Most recent
2026-07-01

Of the 446 recalls from Zimmer, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 44 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

326–350 of 446

  • HighFDA (Devices)·Z-1953-2013·2013-08-21

    Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System Instrumentation due to potential tab fracture during use.

    Product
    REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2013·2013-08-21

    Zimmer Trabecular Metal Reverse Shoulder Instrumentation Recalled for Tab Fracture

    Zimmer, Inc. is recalling Trabecular Metal Reverse Shoulder System instrumentation due to a potential for tab fracture during use.

    Product
    REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impact
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1676-2013·2013-07-17

    Zimmer Recalls Mislabelled Shoulder Trial Stem Devices

    Zimmer, Inc. is removing one lot of Bigliani/Flatow Humeral Provisional Stems because 14mm devices were incorrectly etched and packaged as 12mm.

    Product
    Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1620-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fractures During Surgery

    Zimmer, Inc. is recalling Fukuda retractors because they fracture at the grooves during use. The recall includes 722 units distributed worldwide.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1621-2013·2013-07-10

    Zimmer Recalls Fukuda Retractors Due to Fracture Risk During Surgery

    Zimmer, Inc. is recalling Fukuda-type retractors because they may fracture at the grooves during surgical use. This recall expands a 2010 action to include seven additional lots.

    Product
    Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Small Nonsterile 00-4305-019-30. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2013·2013-06-26

    Zimmer Patient Helper Bed Frame Adapter Assembly Recalled for Weak Welds

    Zimmer, Inc. is recalling 344 Patient Helper Bed Frame Adapter Assemblies because they may have a weak weld where the mounting bars attach to the tube.

    Product
    Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1376-2013·2013-06-05

    Zimmer Recalls NEXGEN Complete Knee Solution Tibial Drills

    Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.

    Product
    NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1045-2013·2013-04-10

    Zimmer NexPosure Retractor Portals Recalled for Sterility Risk

    Zimmer, Inc. is recalling 58 NexPosure retractor portals due to a potential breach in the sterile inner pouch, which could lead to product contamination and patient infection.

    Product
    Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, ¿ N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects

    Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.

    Product
    Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.

    Product
    Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.

    Product
    Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.

    Product
    Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.

    Product
    Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0771-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.

    Product
    Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect

    Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.

    Product
    Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Defect

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity below the specified range. The recall includes 275,952 units distributed worldwide.

    Product
    Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for reha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0659-2013·2013-01-16

    Zimmer Ardis Interbody System Inserter Recalled for Release Knob Issues

    Zimmer, Inc. is recalling 170 Ardis Interbody System Inserters because the release knob may be difficult to turn, potentially leaving the implant engaged in the patient.

    Product
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2013·2013-01-02

    Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation

    Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.

    Product
    Zimmer Spine Ardis Inserter, Rx, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling 318 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0544-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk

    Zimmer, Inc. is recalling 195 Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0549-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Related Tools

    Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and related tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0546-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Drill Guide

    Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0547-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools

    Zimmer, Inc. is recalling Persona Knee System tibial broaches and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Col
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0553-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide