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Implants & Prosthetics

🏥 Medical Devices • 4,589 recalls

Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is 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.

Biomet

Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM

Biomet

Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

Heartware

Class I - Dangerous

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Apr 3, 2020 Implants & Prosthetics View Details →

Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM 189426 Vanguard Knee System, PS Mono Lock Tibial Bearing, 16 MM X 63 MM 189440 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 71 MM

Biomet

Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Generator (IPG) for spinal cord stimulation. The extension may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a permanent IPG is implanted. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Device Registration Form/Temporary Patient Identification Card (1) Manual

Boston Scientific Neuromodulation

Class I - Dangerous

The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

Apr 24, 2019 Implants & Prosthetics View Details →

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP

Heartware

Class I - Dangerous

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Apr 3, 2020 Implants & Prosthetics View Details →

Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

Biomet

Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

Biomet

Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to assess joint tension and component alignment during surgery. The provisional moveable spikes (spike rail) aids in provisional fixation of the trial. SIZE 1, CATALOG NUMBER: REF 74035831 SIZE 2, CATALOG NUMBER: REF 74035832 SIZE 3, CATALOG NUMBER: REF 74035833 SIZE 4, CATALOG NUMBER: REF 74035834 SIZE 5, CATALOG NUMBER: REF 74035835 SIZE 6, CATALOG NUMBER: REF 74035836 SIZE 7, CATALOG NUMBER: REF 74035837 SIZE 8, CATALOG NUMBER: REF 74035838 SIZE 9, CATALOG NUMBER: REF 74035839 SIZE 10, CATALOG NUMBER: REF 74035840

Smith & Nephew

Class I - Dangerous

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

Jan 28, 2020 Implants & Prosthetics Nationwide View Details →

Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

Biomet

Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

Heartware

Class I - Dangerous

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Apr 3, 2020 Implants & Prosthetics View Details →

K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.

K2M

Class I - Dangerous

The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.