Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 76 of 125
Arrow International Inc
Class II Terminated
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid ad...
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2334-2017 June 21, 2017 Reading, PA
Zimmer Biomet, Inc.
Class II Terminated
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2576-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2575-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Por fullct fem st 16x200mm, Sterile,
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2578-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2557-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H
Reason: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Z-2594-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Segmental fluted stem, 16x250mm bwd, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2572-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Por fullct fem st 20x200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2549-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2558-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Segmental fluted stem, 17x190mm str, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2568-2017 June 21, 2017 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Tibial IM Nail 15mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test f...
Z-2561-2017 June 21, 2017 Warsaw, IN
Acumed LLC
Class II Terminated
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants ...
Reason: The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complai...
Z-2197-2017 June 7, 2017 Hillsboro, OR
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
Reason: Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.
Z-2125-2017 May 31, 2017 Westlake Village, CA
EBI Patient Care, Inc.
Class I Terminated
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Reason: Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity...
Z-2119-2017 May 31, 2017 Guaynabo, PR
EBI Patient Care, Inc.
Class I Terminated
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Reason: Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity...
Z-2118-2017 May 31, 2017 Guaynabo, PR
Aesculap Implant Systems LLC
Class II Terminated
GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAMOND BURR COARSE D3.0; GP323R; ELAN 4 2-RING DIAMOND BURR COARSE D4.0; GP324R; ELAN 4 2-RING DIAMOND BURR COARSE D5.0;...
Reason: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m...
Z-2088-2017 May 24, 2017 Center Valley, PA
Zimmer Gmbh
Class II Terminated
Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrume...
Reason: the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
Z-2111-2017 May 24, 2017 Winterthur
Aesculap Implant Systems LLC
Class II Terminated
GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2.0; GP163R; ELAN 4 1-RING DIAMOND BURR COARSE D2,3; GP164R; ELAN 4 1-RING DIAMOND BURR+ COARSE D2...
Reason: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m...
Z-2087-2017 May 24, 2017 Center Valley, PA
Aesculap Implant Systems LLC
Class II Terminated
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II...
Reason: Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction m...
Z-2089-2017 May 24, 2017 Center Valley, PA
Zimmer Biomet, Inc.
Class II Terminated
NexGen Offset Stem Extension, sizes 14mm and 17mm For use in total arthroplasty.
Reason: Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched ...
Z-2115-2017 May 24, 2017 Warsaw, IN
Eden Spine Europe SA
Class II Terminated
GIZA Vertebral Body Replacement
Reason: Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.
Z-2072-2017 May 24, 2017 Geneva
Mentor Texas, LP.
Class II Terminated
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Reason: Missing Dome Pack accessory.
Z-2070-2017 May 17, 2017 Irving, TX
Arthrex, Inc.
Class II Terminated
Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching
Reason: Some eyelets broke from SwiveLock Anchor on insertion.
Z-2046-2017 May 17, 2017 Naples, FL
Arthrex, Inc.
Class II Terminated
Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5 mm x 24 mm
Reason: Some eyelets broke from SwiveLock Anchor on insertion.
Z-2045-2017 May 17, 2017 Naples, FL
Zimmer Trabecular Metal Technology, Inc.
Class III Terminated
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and...
Reason: This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Informa...
Z-1892-2017 May 10, 2017 Parsippany, NJ