Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 50 of 125
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to ...
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-0502-2020 November 27, 2019 Glens Falls, NY
Neocis Inc.
Class II Terminated
Neocis Guidance System Fiducial Array - Product Usage: The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and th...
Reason: The Fiducial Array may mismatch their measurement files resulting in failed landmark check.
Z-0511-2020 November 27, 2019 Miami, FL
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy...
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-0501-2020 November 27, 2019 Glens Falls, NY
Angiodynamics Inc. (Navilyst Medical Inc.)
Class II Terminated
BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED, UPN H965440210, Cat. No. 44-021 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hy...
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-0503-2020 November 27, 2019 Glens Falls, NY
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Reason: A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
Z-0364-2020 November 20, 2019 Westlake Village, CA
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Reason: packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
Z-0363-2020 November 20, 2019 Westlake Village, CA
Exactech, Inc.
Class II Terminated
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implan...
Reason: Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Z-0361-2020 November 20, 2019 Gainesville, FL
Zimmer Biomet, Inc.
Class II Terminated
SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235802210
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0311-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732 00877000832 00877000936 00877001036 00877001140 00877001240 00877001340 00877001440 00877001540 00877001640...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0334-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003 00877004004 00877004005
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0335-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Connection Screw for NCB Plate, Item No. 0202266002
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0330-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 005220...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0321-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112 00234700114 00234700116 00234700118 00234700206 00234700208 00234700210 00234700212 00234700214 0023...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0308-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
LPS-MOB ART SURF IMPL D 9MM
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0324-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0304-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000 32810600012 32810600013 32855510796 32855510797 32855510799 32855510800 32855510801 32855510805 3285551...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0301-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504 00234800506 00234800508 00234800510 00234800512 00234800514 00234800604 00234800606 00234800608 00234800610 0023...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0314-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0316-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 ...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0325-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 0059790954...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0322-2020 November 13, 2019 Warsaw, IN
LivaNova USA Inc
Class II Ongoing
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. Th...
Reason: Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VN...
Z-0346-2020 November 13, 2019 Houston, TX
Zimmer Biomet, Inc.
Class II Terminated
Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420 0104555440 0104555460 0104555480 0104555485 0104555500 0104555505 0104555520 0104555525
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0300-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012 0202267014 0202267016 0202267018
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0331-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0338-2020 November 13, 2019 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 47235800611 47235800615 472...
Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Z-0317-2020 November 13, 2019 Warsaw, IN