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Surgical Instruments

Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).

American Medical Systems Innovation Center - Silicon Valley

Class I - Dangerous

validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products

May 28, 2015 Surgical Instruments Nationwide View Details →

Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Nidek

Class I - Dangerous

Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Mar 25, 2015 Surgical Instruments View Details →

Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.

Musculoskeletal Transplant Foundation

Class I - Dangerous

Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.

May 27, 2015 Surgical Instruments Nationwide View Details →

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

Northern Digital

Class I - Dangerous

Inadequate curing of adhesive, may cause the two halves of the spheres to separate.

Jun 10, 2015 Surgical Instruments Nationwide View Details →

NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

Northern Digital

Class I - Dangerous

Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

May 20, 2015 Surgical Instruments Nationwide View Details →

A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.

Biomet

Class I - Dangerous

Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.

Jun 17, 2015 Surgical Instruments View Details →

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

Stryker Instruments Div. of Stryker

Class I - Dangerous

Potential sterility breach in the packaging.

May 8, 2015 Surgical Instruments Nationwide View Details →

Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

Nidek

Class I - Dangerous

Accessories to the GYC-1000 laser were missing Laser Aperture labels.

Mar 25, 2015 Surgical Instruments View Details →

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

Synthes (USA) Products

Class I - Dangerous

The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

Jun 10, 2015 Surgical Instruments Nationwide View Details →

Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Class I - Dangerous

Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).

May 1, 2015 Surgical Instruments Nationwide View Details →

PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Bard Access Systems

Class I - Dangerous

Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrect expiration dates on the primary labeling.

May 27, 2015 Surgical Instruments Nationwide View Details →

Surgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgery

Stradis Healthcare

Class I - Dangerous

Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.

Apr 20, 2015 Surgical Instruments Nationwide View Details →

The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis.

Maquet Cardiovascular Us Sales

Class I - Dangerous

Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.

May 29, 2015 Surgical Instruments Nationwide View Details →