Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 99 of 125
Nobel Biocare Usa Llc
Class II Terminated
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if t...
Reason: One dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
Z-2074-2015 July 22, 2015 Yorba Linda, CA
Biomet, Inc.
Class II Terminated
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Reason: Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Z-2058-2015 July 22, 2015 Warsaw, IN
Synthes, Inc.
Class II Terminated
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to ...
Reason: It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are bei...
Z-2092-2015 July 22, 2015 West Chester, PA
Zimmer, Inc.
Class II Terminated
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Reason: A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for ...
Z-2060-2015 July 22, 2015 Warsaw, IN
3M Company - Health Care Business
Class II Terminated
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Rest...
Reason: 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.
Z-2052-2015 July 15, 2015 Saint Paul, MN
Alliance Partners LLC
Class II Terminated
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine...
Reason: Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate...
Z-1989-2015 July 15, 2015 San Antonio, TX
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class II Terminated
Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated.
Reason: The box end label is incorrectly labeled as Titanium instead of Stainless Steel on one lot of implantable Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Ste...
Z-2053-2015 July 15, 2015 Marquette, MI
Allergan Inc
Class II Terminated
Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton.
Reason: Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.
Z-1988-2015 July 15, 2015 Irvine, CA
Vascutek, Ltd.
Class II Terminated
Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or ce...
Reason: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Z-1912-2015 July 8, 2015 Inchinnan
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Class II Terminated
Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-...
Reason: Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.
Z-1916-2015 July 8, 2015 Marquette, MI
Vascutek, Ltd.
Class II Terminated
Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or ce...
Reason: Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.
Z-1913-2015 July 8, 2015 Inchinnan
Zimmer, Inc.
Class I Terminated
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and...
Reason: Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than allowed cytotoxicity levels fou...
Z-1699-2015 June 17, 2015 Warsaw, IN
Orthofix, Inc
Class II Terminated
ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
Reason: The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instea...
Z-1749-2015 June 17, 2015 Lewisville, TX
Medtronic Neuromodulation
Class II Terminated
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system t...
Reason: Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
Z-1681-2015 June 3, 2015 Minneapolis, MN
Codman & Shurtleff, Inc.
Class II Terminated
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 G...
Reason: Needle is leaking from hub/needle cannula connection
Z-1684-2015 June 3, 2015 Raynham, MA
DePuy Orthopaedics, Inc.
Class II Terminated
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Reason: The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS CO...
Z-1673-2015 June 3, 2015 Warsaw, IN
DePuy Orthopaedics, Inc.
Class II Terminated
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Reason: The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS CO...
Z-1672-2015 June 3, 2015 Warsaw, IN
Medtronic Neuromodulation
Class II Terminated
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Reason: Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 370...
Z-1617-2015 May 27, 2015 Minneapolis, MN
BioHorizons Implant Systems Inc
Class II Terminated
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
Reason: BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Z-1605-2015 May 20, 2015 Hoover, AL
Bard Access Systems
Class II Terminated
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Winged Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling th...
Reason: Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety In...
Z-1560-2015 May 6, 2015 Salt Lake City, UT
Coloplast Manufacturing US, LLC
Class II Terminated
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be im...
Reason: Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is print...
Z-1538-2015 May 6, 2015 Minneapolis, MN
Medical Components, Inc dba MedComp
Class II Terminated
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide r...
Reason: The dual port with catheters was not covered under FDA clearance.
Z-1527-2015 May 6, 2015 Harleysville, PA
Laax, Inc.
Class I Terminated
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Reason: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or ...
Z-1461-2015 April 29, 2015 Livermore, CA
Exactech, Inc.
Class II Terminated
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Reason: Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
Z-1459-2015 April 29, 2015 Gainesville, FL
Laax, Inc.
Class I Terminated
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Reason: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or ...
Z-1462-2015 April 29, 2015 Livermore, CA