Medical Device Recalls

Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device

Brius Technologies Inc.

Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 7821

Philips North America

RayStation 11B

RAYSEARCH LABORATORIES AB

Mazor X robotic guidance system REF: TPL0059

Mazor Robotics Ltd

SURGIMESH XB, Polymeric Surgical Mesh, 14m x 15cm Flat Sheet with Silicone Barrier, Model/Catalog Number: Tintra R-1415

Chamberlain Technologies LLC

DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d)

Delta Med SpA

Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD

Vortex Surgical Inc.

Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium

The Anspach Effort, Inc.

See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Numb

Medline Industries, LP

ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

ICU Medical, Inc.

Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A136 used in conjunction with Warming

Augustine Temperature Management, LLC

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095

TELEFLEX LLC

Dialyzer Optiflux 160NRe

Fresenius Medical Care Holdings, Inc.

Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01

Biomet, Inc.

Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;

Philips North America Llc

Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/

Medical Action Industries, Inc. 306

ProCuity bed series, model number 3009, item number: 300900000000,

Stryker Medical Division of Stryker Corporation

Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems

Siemens Medical Solutions USA, Inc.

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

SAFE ORTHOPAEDICS LLC

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty su

Howmedica Osteonics Corp.

AirFit N20 Nasal Mask and User Guide

ResMed Ltd.

Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis

Baxter Healthcare Corporation

X-Guide Handpiece Adaptor Sleeve 1, Model P010701

X-NAV Technologies, LLC

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Allura Xper FD20 Biplane; Model Number: 722013;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow So

Integra LifeSciences Corp. (NeuroSciences)

Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10

AVID Medical, Inc.

Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software

Abbott Medical

Revogene, Catalog no. 610210. IVD test instrument

Meridian Bioscience Inc

Sensica Urine Output System

C.R. Bard Inc