Stryker Craniomaxillofacial Division - MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPORTitaniumBarrier (MTB) Right - Class 2 Recall
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Stryker Craniomaxillofacial Division - MEDPOR BARRIER Sheets Orbital Floor Implant - Class 2 Recall
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Stryker Craniomaxillofacial Division - MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm - Class 2 Recall
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton. (Source: Medical Device Recalls)
Source: Medical Device Recalls - February 12, 2015 Category: Medical Equipment Source Type: alerts
Customed, Inc - Plastic Surgery Pack - Class 1 Recall
Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
Customed, Inc - Plastic Surgery Pack - Class 1 Recall
Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 1 Recall
Plastic Surgery Pack, Catalog # 900-920 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 16, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - 1488710105 HD 3Chip Inline Camera, CMount - Class 2 Recall
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - 1488 HD 3Chip Camera; Model Number 1488210105 CMount - Class 2 Recall
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Stryker Endoscopy - 1488 HD 3Chip Camera; Model Number 1488210105 CMount - Class 2 Recall
1488 HD 3-Chip Camera; Model Number 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 13, 2014 Category: Medical Equipment Source Type: alerts
Mentor Texas, LP. - MENTOR Sterile Saline Mammary Volume Sizer - Class 2 Recall
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted. Mentor Sterile Saline Mammary Volume Sizer (Sizer) is a silicone elastomer device designed for temporary intraoperative placement in the surgically prepared mammary pocket. The Sizer is used to evaluate the appropriate mammary prosthesis volume for each patient prior to implant of a mammary prosthesis. The Sizer ...
Source: Medical Device Recalls - September 5, 2014 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 1 Recall
PLASTIC SURGERY PACK- (1) MAYO STAND COVER REINFORCED LIF (1) CAUTERY TIP POLISHER LIF (1) BAG SUTURE FLORAL L/F (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (20) GAUZE SPONGES 4" X 4" 4PL Y (1) COVER TABLE REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) PENCIL CAUTERY HANDSWITCHING L/F (1) TUBE SUCTION CONNECT. ~, X 12' LIF (1 0) LAP SPONGE PRE-WASH XRD LIF (2) LITE GLOVE LIF (4) HUCK CLOTH TOWEL BLUE (2) DRAPE SHEET MEDIUM 41" X 69" LIF (2) NEEDLE & BLADE COUNTER 1 OC MAG/CLEAR LIF (1) DRAPE LAP ABDOMINAL WITH POUCH STD SMS (5) Pk. STERI STRIP CL...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 1 Recall
Breast Implant Pack, Code 900-2660, contains: (1) DRAPE ECONOMY 53 X 77 (3) GOWN SOFT SMS STANDARD XLGE SET IN SLEEVE (3) TOWELS ABSORBENT 15 X 20 (1) MAYO STAND COVER REINFORCED (2) TABLE COVER REINFORCED 50 X 90 (1) SUTURE BAG FLORAL (1) TUBE SUCTION CONNECT Y (6) TOWEL CLOTH HUCK BLUE (4) PAD ABDOMINAL 8 X 7.5 (2) LITE GLOVES (1) CAUTERY TIP POLISHER LIF (1) BLADE SURGICAL CARBON STEEL 15 (1) YANKAUER SUCTION TUBE W/0 VENT (1 0) LAP SPONGE PREWASH 18 X 18 XRD (1) CAUTERY PENCIL ROCKER SWITCH W/HOLSTER (1) UNDERPAD 23 X 36 Product Usage: EO sterilized surgical convenient packs packaged into polyester/p...
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts
Customed, Inc - Class 1 Recall
PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X 26" LIF (30) COTION TIP APPLIC 6" WOOD LIF (1) PVP PAINT 8" STICK SPONGE (1) NEEDLE & BLADE COUNTER 20C FOAM I MAG L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (Source: Medical Device Recalls)
Source: Medical Device Recalls - August 30, 2014 Category: Medical Equipment Source Type: alerts
Laser Peripherals LLC - DBLF602 Bare Laser fiber - Class 2 Recall
LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 18, 2014 Category: Medical Equipment Source Type: alerts
Aesculap, Inc. - Aesculap GNI161 Bipolar Foot Control - Class 2 Recall
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 12, 2013 Category: Medical Equipment Source Type: alerts
