Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 98 of 125
Limacorporate S.p.A
Class II Terminated
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
Reason: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Z-2540-2015 September 9, 2015 San Daniele Del Friuli, N/A
Trilliant Surgical Ltd.
Class II Terminated
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and ...
Reason: The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Z-2452-2015 September 2, 2015 Houston, TX
Trilliant Surgical Ltd.
Class II Terminated
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless...
Reason: Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
Z-2464-2015 September 2, 2015 Houston, TX
Omnilife Science Inc.
Class II Terminated
Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip S...
Reason: The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that ...
Z-2455-2015 September 2, 2015 East Taunton, MA
Omnilife Science Inc.
Class II Terminated
Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip...
Reason: The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that ...
Z-2454-2015 September 2, 2015 East Taunton, MA
Stryker Howmedica Osteonics Corp.
Class II Terminated
Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromise...
Z-2429-2015 August 26, 2015 Mahwah, NJ
Trilliant Surgical Ltd.
Class II Terminated
2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation Syst...
Reason: The cutting efficiency of the Countersinks was out of specification.
Z-2421-2015 August 26, 2015 Houston, TX
Stryker Howmedica Osteonics Corp.
Class II Terminated
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
Reason: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromise...
Z-2427-2015 August 26, 2015 Mahwah, NJ
Synthes (USA) Products LLC
Class II Terminated
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use wi...
Reason: The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. ...
Z-2359-2015 August 19, 2015 West Chester, PA
B. Braun Interventional Systems
Class II Terminated
Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to t...
Reason: The manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).
Z-2382-2015 August 19, 2015 Minneapolis, MN
Alcon Research, Ltd.
Class I Terminated
ReSTOR intraocular lens and ReSTOR Toric intraocular lens. The Alcon AcrySof IQ ReSTOR and IQ ReSTOR Toric intraocular lenses are posterior chamber lenses intended as optical implants designed to r...
Reason: There are reports of post - operative inflammation and/or toxic anterior segment syndrome (TASS) after cataract surgery.
Z-2323-2015 August 19, 2015 Fort Worth, TX
TITAN SPINE, LLC
Class II Terminated
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locki...
Reason: Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'.
Z-2327-2015 August 12, 2015 Mequon, WI
Aesculap, Inc.
Class II Terminated
S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervical Spinal System clamping screws with a defined torque 2.8 Nm for tightening the clamping screw in the screw head/hook head/occipita...
Reason: A FW103R torque wrench that was improperly reassembled after reprocessing caused a screw to break during implantation due to too much torque. The firm did not include instructions ...
Z-2326-2015 August 12, 2015 Center Valley, PA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implan...
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re...
Z-2244-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange - GIA Auto Suture Loading Unit w/ DST Series Technology 80mm - 4.8mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number GIA8048L; EXP (repackager), Covidien...
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2217-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2226-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange - Loading Unit w/ DST Series Technology 60mm - 3.5mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number TA6035L; EXP (repackager), Covidien (OEM) Implan...
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2219-2015 August 5, 2015 Fremont, CA
Skeletal Kinetics, Llc
Class II Terminated
InjectionPlasty 1.0 Bone Void Filler; an injectable and biocompatible calcium phosphate bone void filler. Sterilized using irradiation. The single-use InjectionPlasty 1.0 Kit contains the necessary ...
Reason: Reports of venous uptake, DVT, pulmonary embolism in patients who were implanted with Injection Plasty Bone Void Filler.
Z-2209-2015 August 5, 2015 Cupertino, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2227-2015 August 5, 2015 Fremont, CA
EXP Pharmaceutical Services Corp
Class II Terminated
Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45MM STAPLE; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number ATS45; EXP (repackager), Ethicon (OEM) ...
Reason: EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were r...
Z-2229-2015 August 5, 2015 Fremont, CA
Encore Medical, Lp
Class II Terminated
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Reason: The markings on the distal face of the instruments are mis-oriented by 180¿. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the r...
Z-2262-2015 August 5, 2015 Austin, TX
Bausch & Lomb Surgical, Inc.
Class II Terminated
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia s...
Reason: Haptics breaking during lens loading and insertion.
Z-2154-2015 July 29, 2015 Clearwater, FL
Cochlear Americas Inc.
Class II Terminated
Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and dep...
Reason: Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
Z-2155-2015 July 29, 2015 Centennial, CO
Allergan Inc
Class II Terminated
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive ...
Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.
Z-2104-2015 July 29, 2015 Irvine, CA
Allergan Inc
Class II Terminated
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile...
Reason: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Z-2103-2015 July 29, 2015 Irvine, CA