MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
Reason: The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box a...
Z-0279-2016November 25, 2015Eden Prairie, MN
Biomet 3i, LLC
Class IITerminated
Biomet 3i Narrow Right Angle Large Driver Tip (Hexed). Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and ...
Reason: The RASH3N, a hexed, abutment screw driver tip has been labeled and distributed as RASQ3N, a square, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser...
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capt...
Reason: Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.
Z-0249-2016November 18, 2015Mahwah, NJ
Biomet 3i, LLC
Class IITerminated
Biomet 3i Narrow Right Angle Square Driver Tip. Driver tips are attached to a surgical drilling unit to carry components such as implant mounts, healing abutments and screws for placement and removal...
Reason: RASQ3N, a square, abutment screw driver tip has been labeled and distributed as RASH3N, a hexed, abutment screw driver tip. Additionally, the RASQ3N received the RASH3N's laser ma...
Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.
Reason: The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was r...
Z-0236-2016November 18, 2015West Chester, PA
Exactech, Inc.
Class IITerminated
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Reason: Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Z-0201-2016November 11, 2015Gainesville, FL
Bard Peripheral Vascular Inc
Class IITerminated
FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expande...
Reason: Bard Peripheral Vascular (BPV) is recalling the Bard Flair Endovascular Stent Graft because of the harm associated with failure to deploy or deployment related issues that could oc...
Z-0223-2016November 11, 2015Tempe, AZ
Encore Medical, Lp
Class IITerminated
Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture i...
Reason: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titaniu...
Z-0179-2016November 4, 2015Austin, TX
Encore Medical, Lp
Class IITerminated
Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. T...
Reason: During the assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plas...
Reason: May contain small amounts of ethylene glycol residue
Z-0147-2016October 28, 2015Bedford, MA
Biomet Microfixation, LLC
Class IITerminated
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
Reason: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Reason: May contain small amounts of ethylene glycol residue
Z-0144-2016October 28, 2015Bedford, MA
Biomet Microfixation, LLC
Class IITerminated
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
Reason: The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Z-0137-2016October 28, 2015Jacksonville, FL
Smiths Medical ASD, Inc.
Class IITerminated
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpo...
Reason: The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The p...
Z-0152-2016October 28, 2015Saint Paul, MN
Zimmer Gmbh
Class IITerminated
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Reason: In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another impla...
Z-0119-2016October 21, 2015Winterthur, N/A
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class IITerminated
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system....
Reason: The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
Z-0120-2016October 21, 2015Irvine, CA
Medtronic Inc. Cardiac Rhythm Disease Management
Class IITerminated
Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. Th...
Reason: Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of...
Z-0022-2016October 14, 2015Saint Paul, MN
Zimmer, Inc.
Class IITerminated
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation...
Reason: It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect sil...
Z-0027-2016October 14, 2015Warsaw, IN
Synthes (USA) Products LLC
Class IITerminated
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixatio...
Reason: DLS pin breakage during planned implant removal, after uneventful and successful healing of the fracture. This notice to additional consignees identified after recall Z-0390-2014,...
Z-2794-2015September 30, 2015West Chester, PA
Stryker Howmedica Osteonics Corp.
Class IITerminated
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Reason: it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts wer...
Z-2810-2015September 30, 2015Mahwah, NJ
Biomet 3i, LLC
Class IITerminated
UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient.
Reason: MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
St Jude Medical Cardiac Rhythm Management Division
Class IITerminated
Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's.
Reason: Some devices exhibit backup VVI operation due to a backup reset.
Z-2784-2015September 23, 2015Sylmar, CA
Customed, Inc
Class IITerminated
ORTHO-IMPLANT SURGICAL PACK, Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2700-2015September 9, 2015Fajardo, PR
Limacorporate S.p.A
Class IITerminated
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 m...
Reason: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
Z-2539-2015September 9, 2015San Daniele Del Friuli, N/A
Customed, Inc
Class IITerminated
IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.