Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 58 of 125
Zimmer Biomet, Inc.
Class II Terminated
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for ...
Reason: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Z-0540-2019 December 12, 2018 Warsaw, IN
Boston Scientific Corporation
Class II Terminated
The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of ...
Reason: Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.
Z-0474-2019 November 28, 2018 Saint Paul, MN
Arthrex, Inc.
Class II Ongoing
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. ...
Reason: There is potential to break during use.
Z-0442-2019 November 21, 2018 Naples, FL
Straumann Manufacturing, Inc.
Class II Terminated
Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in...
Reason: Laser engraved label does not match with the item in the package
Z-0455-2019 November 21, 2018 Andover, MA
Zimmer Biomet, Inc.
Class II Terminated
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem...
Reason: There is a potential for comingling of the 43MM and 51 MM molds
Z-0399-2019 November 14, 2018 Warsaw, IN
Integrity Implants Inc.
Class II Terminated
FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graf...
Reason: Recently Integrity Implants uncovered a discrepancy in the cleaning parameters in several of their labeling material. The firm is initiating the field correction to ensure that upd...
Z-0405-2019 November 14, 2018 Cooper City, FL
Coltene Whaledent Inc
Class II Terminated
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a...
Reason: ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Z-0376-2019 November 14, 2018 Cuyahoga Falls, OH
DT MedTech, LLC
Class II Terminated
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Reason: Incorrect package labeling identifying the device
Z-0403-2019 November 14, 2018 Towson, MD
Zimmer Biomet, Inc.
Class I Terminated
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success ...
Reason: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Z-0287-2019 November 7, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class I Terminated
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Reason: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Z-0286-2019 November 7, 2018 Warsaw, IN
Nakanishi Inc.
Class II Terminated
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant ...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0226-2019 October 31, 2018 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping t...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev...
Z-0220-2019 October 31, 2018 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant u...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0224-2019 October 31, 2018 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping th...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev...
Z-0219-2019 October 31, 2018 Kanuma, N/A
Howmedica Osteonics Corp.
Class II Terminated
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter i...
Reason: The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrica...
Z-0207-2019 October 31, 2018 Allendale, NJ
Smith & Nephew, Inc.
Class II Terminated
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the...
Reason: One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Z-0200-2019 October 31, 2018 Memphis, TN
Nakanishi Inc.
Class II Terminated
Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0222-2019 October 31, 2018 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant u...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0223-2019 October 31, 2018 Kanuma, N/A
Alcon Research, LTD.
Class I Terminated
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Reason: Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) com...
Z-0186-2019 October 31, 2018 Sinking Spring, PA
Nakanishi Inc.
Class II Terminated
Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping t...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The prev...
Z-0221-2019 October 31, 2018 Kanuma, N/A
Nakanishi Inc.
Class II Terminated
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant...
Reason: Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previ...
Z-0225-2019 October 31, 2018 Kanuma, N/A
Alcon Research, LTD.
Class I Terminated
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Reason: Analysis of the completed dataset from the COMPASS-XT long-term study showed that the CyPass Micro-Stent group experienced statistically significant endothelial cell loss (ECL) com...
Z-0188-2019 October 31, 2018 Sinking Spring, PA
Philips Electronics North America Corp.
Class II Terminated
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden c...
Reason: Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Z-0175-2019 October 24, 2018 Bothell, WA
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Reason: Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
Z-0089-2019 October 17, 2018 Thousand Oaks, CA
Rayner Intraocular Lenses Limited
Class II Terminated
C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following pha...
Reason: Firm become aware of reports of post-operative refractive errors following implantation of lenses.
Z-3282-2018 October 10, 2018 Worthing