Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation r...
Reason: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Z-0219-2020November 6, 2019Warsaw, IN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de...
Z-0240-2020November 6, 2019Mounds View, MN
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ ...
Reason: The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position ...
Z-0261-2020November 6, 2019Westlake Village, CA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Reason: There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac de...
Z-0241-2020November 6, 2019Mounds View, MN
OrthoPediatrics Corp
Class IITerminated
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (pr...
Reason: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Z-0218-2020November 6, 2019Warsaw, IN
Exactech, Inc.
Class IITerminated
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacemen...
Reason: Potential for the wire to fracture at the threads and remain in the glenoid.
Z-0168-2020October 30, 2019Gainesville, FL
OrthoPediatrics Corp
Class IITerminated
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the in...
Reason: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Reason: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Z-0040-2020October 16, 2019Roswell, GA
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Reason: The incorrect device was packaged in the vial.
Z-0010-2020October 9, 2019Westlake Village, CA
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on th...
Reason: Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
Z-0018-2020October 9, 2019Westlake Village, CA
Paltop Advanced Dental Solutions Ltd
Class IITerminated
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Reason: Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant.
Z-0019-2020October 9, 2019Caesarea, N/A
Zimmer GmbH
Class IITerminated
Sidus Stem-Free Shoulder Humeral Head 50-18 Item number: 01.04555.500 orthopedic implant - Product Usage: The Sidus Stem-Free Shoulder is designed for long-term implantation into the human shoulder j...
Reason: Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
Z-2762-2019October 9, 2019Winterthur, N/A
GETINGE US SALES LLC
Class IITerminated
The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascul...
Reason: Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product wit...
Reason: Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component ...
Reason: Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component ...
Z-2543-2019September 25, 2019Saint Paul, MN
Allergan PLC
Class IOngoing
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection un...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2458-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
RITZ PRINCESS, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles RML, RMM, RFL, RFM Product Usage: Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2464-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
McGhan BioDIMENSIONAL silicone-Filled Breast Implants, style 153 Product Usage: Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2459-2019September 18, 2019Irvine, CA
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Reason: Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micr...
Z-2493-2019September 18, 2019Mounds View, MN
Allergan PLC
Class IOngoing
Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2452-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion S...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2455-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2457-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...
Z-2463-2019September 18, 2019Irvine, CA
Allergan PLC
Class IOngoing
Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:1...
Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lympho...