369 results
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21ms
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Sources: EU EUDAMED, US FDA
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Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF CP460193. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 18, 2008
Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF RD425032. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 18, 2008
Compress Instrument Anchor Plug Holder, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481006. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 18, 2008
Compress Short Anchor Plug Holder, 13mm, Biomet Orthopedics, Inc., Warsaw, IN; REF CP461038. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 18, 2008
Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 18, 2008
Custom biomodular humeral tray 44 mm sterile, REF CP561686, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Custom comprehensive reverse shoulder bio-modular base 44 mm humeral tray standard, REF CP561510, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +10 mm, sterile, single use, REF 115348, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Custom comprehensive reverse humeral tray set w/ lock rings 44 mm + 15 mm & + 18 mm sterile, REF CP561705, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Custom solar comprehensive reverse humeral tray with lock ring 44 mm +5mm, sterile, REF CP561659, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Custom bi-angular to reverse shoulder humeral tray 44 mm sterile, REF CP561548, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Bio-modular reverse shoulder humeral tray with lock ring, 44 mm standard, sterile, single use, REF 11-113680, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Comprehensive reverse shoulder humeral tray with locking ring, 44 mm standard, sterile, single use, REF 115340, Biomet Orthopedics, Warsaw, IN. 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 Recall
Terminated
·Biomet, Inc.·Product code KWS·April 22, 2011
Vanguard 360 Revision Knee System Knee prostheses
FDA Recall
Terminated
·Zimmer Biomet, Inc.·Product code JWH·August 8, 2016
Avenir Mller Stem 4 Standard Avenir Mller Stem 6 Lateral Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
FDA Recall
Terminated
·Product code LZO·June 30, 2016
Biomet brand Modular Microplasty Cup Inserter, 3/8" thread, Biomet Orthopedics, Inc., Warsaw, IN; Model 31-400600. Non-powered, hand-held instrument intended for use as an impactor during orthopedic surgery.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 28, 2008
Biomet brand Discovery Elbow, 3 mm x 75 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114813. The product intended use is for Orthopedic implant.
FDA Recall
Terminated
·Biomet, Inc.·Product code JDC·May 23, 2008
Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
FDA Recall
Terminated
·Biomet, Inc.·Product code JDC·May 23, 2008