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Implants & Prosthetics

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.

DePuy Orthopaedics

Class I - Dangerous

The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.

Mar 4, 2015 Implants & Prosthetics Nationwide View Details →

Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter

Medtronic Neuromodulation

Class I - Dangerous

Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.

Apr 10, 2015 Implants & Prosthetics Nationwide View Details →

Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.

Stryker Howmedica Osteonics

Class I - Dangerous

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Aug 15, 2014 Implants & Prosthetics Nationwide View Details →

Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint

Stryker Howmedica Osteonics

Class I - Dangerous

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Aug 15, 2014 Implants & Prosthetics Nationwide View Details →

Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.

Stryker Howmedica Osteonics

Class I - Dangerous

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Aug 15, 2014 Implants & Prosthetics Nationwide View Details →

Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.

Stryker Howmedica Osteonics

Class I - Dangerous

Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.

Feb 27, 2015 Implants & Prosthetics Nationwide View Details →

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

BioHorizons Implant Systems

Class I - Dangerous

BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.

Apr 16, 2015 Implants & Prosthetics Nationwide View Details →

NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10. Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.

Zimmer

Class I - Dangerous

The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery

Apr 2, 2015 Implants & Prosthetics View Details →

PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. The PowerLoc MAX SWIS is also indicated for power injection of contrast media into the central venous system only with an implanted port that is also indicated for power injection.

Bard Access Systems

Class I - Dangerous

Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.

Mar 13, 2015 Implants & Prosthetics View Details →

Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

Zimmer Gmbh

Class I - Dangerous

Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.

Mar 18, 2015 Implants & Prosthetics View Details →

9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.

Medical Components, Inc

Class I - Dangerous

The dual port with catheters was not covered under FDA clearance.

Jan 28, 2015 Implants & Prosthetics Nationwide View Details →

Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.

Coloplast Manufacturing US

Class I - Dangerous

Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.

Apr 9, 2015 Implants & Prosthetics Nationwide View Details →

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

Specialty Appliance Works

Class I - Dangerous

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

Specialty Appliance Works

Class I - Dangerous

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance.

Specialty Appliance Works

Class I - Dangerous

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

Laax

Class I - Dangerous

Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.

Mar 25, 2015 Implants & Prosthetics Nationwide View Details →