2,655 results · 31ms · Sources: EU EUDAMED, US FDA

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Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581

FDA Recall
Terminated ·Biomet, Inc.·Product code JWH·December 12, 2007

Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581

FDA Recall
Terminated ·Biomet, Inc.·Product code JWH·December 12, 2007

Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·September 21, 2007

Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195 (in Europe), Biomet, Inc., Warsaw, IN

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·September 21, 2007

OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

FDA Enforcement
Class II ·Terminated·Nidek Inc·August 24, 2016

Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·December 24, 2014

Biomet RINGLOC + Instrumentation Impactor Plate, Size 21; REF 31-400621,Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

Segmental fluted stem, 18x250mm bwd, Sterile,

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

Por fullct fem st 17x200mm, Sterile,

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

Por fullct fem st 18x200mm, Sterile,

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

Por fullct fem st 16x200mm, Sterile,

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·December 24, 2014

Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

Biomet RINGLOC + Instrumentation Impactor Plate, Size 20; REF/Part #: 31-400620, Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

Biomet RINGLOC + Instrumentation Impactor Plate, Size 26; REF/Part#: 31-400626, Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

Biomet RINGLOC + Instrumentation Impactor Plate, Size 22; REF/Part#: 31-400622, Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

Biomet RINGLOC + Instrumentation Impactor Plate, Size 23; REF/Part#: 31-400623, Biomet Orthopedics, Inc., Warsaw, IN.

FDA Recall
Terminated ·Biomet, Inc.·Product code LXH·October 18, 2007

Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.

FDA Recall
Terminated ·Biomet, Inc.·Product code JWH·July 6, 2011

Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·March 16, 2016

Fem IM Nail 15mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017