Recall archive
156 recalls · page 4 of 7
Reported Apr 11, 2018
A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The drill guides were manufactured with the incorrect color anodization.
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Biomet, Inc.
Matched: Brand · Product · Product details — During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral…
FDA (openFDA device enforcement)
Reported Apr 4, 2018
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper…
19 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 21, 2018
Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Two lots of hip implants are mislabeled.
58 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 14, 2018
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The Sirus Drill and Flexible Shaft instruments may not be adequately cleaned when utilizing the standard cleaning instructions potentially resulting…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 7, 2018
Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2018
ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Robot arm being sent to the wrong position
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Potential for the Persona Partial Knee Impactor Pad to fracture.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 14, 2018
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2018
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an…
64 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2018
Persona Partial Knee System, Size 8, Finishing Guide
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in…
FDA (openFDA device enforcement)
Reported Jan 10, 2018
Lateral Troch Plate Full Crimp - 254mm, model # 350837
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified…
10 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2017
ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular…
FDA (openFDA device enforcement)
Reported Dec 6, 2017
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2017
ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 22, 2017
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Possible break in the connector of the Force Sensor.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2017
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was…
FDA (openFDA device enforcement)
Reported Oct 4, 2017
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or…
59 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 20, 2017
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
FDA (openFDA device enforcement)
Reported Aug 9, 2017
ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Complaint of the head holder connector locking up mechanically when tightened.
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to…
42 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 7, 2017
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand — Durability characteristics of reusable instruments were not established
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 24, 2017
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints…
FDA (openFDA device enforcement)
Reported May 17, 2017
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Zimmer Biomet, Inc.
Matched: Brand · Reason for recall — Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss…
2 more products in this recall
FDA (openFDA device enforcement)
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