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Implants & Prosthetics

🏥 Medical Devices • 4,589 recalls

Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameters and lengths

Boston Scientific

Class I - Dangerous

Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm

Mar 18, 2016 Implants & Prosthetics Nationwide View Details →

Trinity Acetabular Shell Product Usage Total Hip Replacement.

Corin USA Limited

Class I - Dangerous

Potential for abrasion of the sterile barrier pouches of the new packaging system.

Jan 29, 2016 Implants & Prosthetics Nationwide View Details →

Trinity Acetabular Shell Product Usage: Total Hip Replacement.

Corin USA Limited

Class I - Dangerous

Potential for abrasion of the sterile barrier pouches of the new packaging system.

Jan 29, 2016 Implants & Prosthetics Nationwide View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Smith & Nephew

Class I - Dangerous

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Mar 11, 2016 Implants & Prosthetics View Details →

Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Customed

Class I - Dangerous

Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Jan 7, 2016 Implants & Prosthetics View Details →

Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.

Arthrex

Class I - Dangerous

Potential for a component contained in the Implant System to be non-sterile.

Jan 11, 2016 Implants & Prosthetics Nationwide View Details →

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