ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason: The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Z-0790-2020January 15, 2020Thousand Oaks, CA
Stryker GmbH
Class IITerminated
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-00...
Reason: Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and remo...
Z-0780-2020January 15, 2020Selzach, N/A
AAP Implantate Ag
Class IIITerminated
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Reason: Products were distributed with the incorrect instructions for use.
Z-0732-2020January 1, 2020Berlin
AAP Implantate Ag
Class IIITerminated
INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
Reason: Products were distributed with the incorrect instructions for use.
Z-0731-2020January 1, 2020Berlin
Allergan PLC
Class IIITerminated
Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and Sizes: 7607 SSM, 7608 SSF, 7609 SSX, 7513 SRL, 7514 SRLP, 7515 SRM, 7516 SRF, 7517 SRX, 7626 SCL, 7627 SCLP, 7628 SCM, 76...
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l...
Z-0701-2020December 25, 2019Irvine, CA
Integra Lifesciences Sales Llc
Class IITerminated
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint...
Reason: Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Z-0691-2020December 25, 2019Plainsboro, NJ
Allergan PLC
Class IIITerminated
Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NAT...
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l...
Z-0700-2020December 25, 2019Irvine, CA
Allergan PLC
Class IIITerminated
Natrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Sty...
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l...
Z-0699-2020December 25, 2019Irvine, CA
Allergan PLC
Class IIITerminated
NATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L ...
Reason: The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-l...
Z-0702-2020December 25, 2019Irvine, CA
Smith & Nephew, Inc.
Class IITerminated
smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Product Usage: The PROFIX Mallet is a reusable surgical instrument used to tap instruments or implants during knee or hip surgery.
Reason: There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure ...
Z-0696-2020December 25, 2019Memphis, TN
DePuy Mitek, Inc., a Johnson & Johnson Co.
Class IITerminated
Healix Knotless ADV BR 4.75 Suture Anchor
Reason: Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Materia...
Z-0665-2020December 18, 2019Norwood, MA
DePuy Mitek, Inc., a Johnson & Johnson Co.
Class IITerminated
Healix Knotless ADV BR 5.5 Suture Anchor
Reason: Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Materia...
Z-0666-2020December 18, 2019Norwood, MA
Conformis, Inc.
Class IITerminated
iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint ...
Reason: Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Z-0672-2020December 18, 2019Billerica, MA
Encore Medical, Lp
Class IIOngoing
EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Reason: The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant ...
Z-0611-2020December 18, 2019Austin, TX
Paragon 28, Inc.
Class IITerminated
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
Reason: It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of t...
Z-0662-2020December 18, 2019Englewood, CO
Miami Device Solutions, LLC.
Class IITerminated
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractu...
Reason: Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Z-0603-2020December 11, 2019Miami, FL
Allergan PLC
Class IIOngoing
XEN Gel Stent, REF 5513-001(US Model), Sterile, RX Only, (01)10888628032439 ; Other Model Numbers: 5507-001(Global Model) and 5517-001(Australia model) Implant for glaucoma treatment.
Reason: Residual polishing compounds, that are used in the needle sleeve manufacturing process, may be present on the injector needle. The residual polishing compounds could transfer to th...
Z-0598-2020December 11, 2019Irvine, CA
Wright Medical Technology, Inc.
Class IITerminated
SWANSON TRAPEZIUM IMPLANT, Part Number 4520002
Reason: The firm discovered a lack of adequate documentation confirming sterility on certain products.
Z-0572-2020December 4, 2019Arlington, TN
Zimmer Biomet, Inc.
Class IITerminated
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0531-2020December 4, 2019Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0529-2020December 4, 2019Warsaw, IN
Bard Peripheral Vascular Inc
Class IIOngoing
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason: Complaints received that products packaged with the incorrect introducer sheath size.
Z-0582-2020December 4, 2019Tempe, AZ
Howmedica Osteonics Corp.
Class IITerminated
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
Reason: Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015)
Z-0514-2020December 4, 2019Mahwah, NJ
Zimmer Biomet, Inc.
Class IITerminated
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connec...
Z-0504-2020November 27, 2019Glens Falls, NY
Angiodynamics Inc. (Navilyst Medical Inc.)
Class IITerminated
XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to h...
Reason: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connec...