NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1438-2015April 22, 2015Yorba Linda, CA
Biomet 3i, LLC
Class IITerminated
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Reason: Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Z-1411-2015April 22, 2015Palm Beach Gardens, FL
Nobel Biocare Usa Llc
Class IITerminated
NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1426-2015April 22, 2015Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arch...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1421-2015April 22, 2015Yorba Linda, CA
Nobel Biocare Usa Llc
Class IITerminated
Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arc...
Reason: A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Z-1416-2015April 22, 2015Yorba Linda, CA
Boston Scientific Corporation
Class IITerminated
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainag...
Reason: Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for devic...
Z-1336-2015April 8, 2015Maple Grove, MN
Boston Scientific Corporation
Class IITerminated
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Reason: Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retr...
Reason: Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III beca...
Z-1351-2015April 8, 2015Harleysville, PA
Medtronic Inc. Cardiac Rhythm Disease Management
Class IITerminated
Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a...
Reason: Possible performance issue when used with specific AA-sized (LR6) batteries. The negative terminal of a commercially available AA (LR6) battery did not maintain a sufficient connec...
Z-1356-2015April 8, 2015Saint Paul, MN
Pega Medical Inc.
Class IITerminated
GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for th...
Reason: Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial ps...
Z-1362-2015April 8, 2015Laval, N/A
DePuy Orthopaedics, Inc.
Class IITerminated
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Reason: This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Reason: Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder.
Z-1318-2015April 1, 2015Ecully
Aaren Scientific, Incorporated
Class IITerminated
Intraocular Lens (IOL), Part No. EC-3 PAL, Diopter: 17.5, 18.0, 18.5, 19.0, 19.5, 21.5, 23.5, 9.0, 22.5, 23.0, 21.0, 24.0. The device is indicated for primary implantation in the capsular bag of t...
Reason: Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
Z-1309-2015April 1, 2015Ontario, CA
Medtronic Inc. Cardiac Rhythm Disease Management
Class ITerminated
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of...
Reason: Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Z-1276-2015March 25, 2015Saint Paul, MN
Synthes, Inc.
Class IITerminated
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is p...
Reason: The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the f...
Z-1260-2015March 18, 2015West Chester, PA
Southern Implants, Inc
Class IITerminated
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper a...
Reason: Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.
Z-1265-2015March 18, 2015Irvine, CA
Biomet Spine, LLC
Class IITerminated
Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tu...
Reason: Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
Z-1146-2015March 4, 2015Broomfield, CO
Stryker Craniomaxillofacial Division
Class IITerminated
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/co...
Reason: Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively...
Z-1091-2015February 18, 2015Portage, MI
Stryker Craniomaxillofacial Division
Class IITerminated
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-w...
Reason: Potential for implant damage, implant cracking off/breaking intra-operatively.
Z-1090-2015February 18, 2015Portage, MI
Stryker Craniomaxillofacial Division
Class IITerminated
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applicati...
Reason: Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the sh...
Z-1093-2015February 18, 2015Portage, MI
Stryker Craniomaxillofacial Division
Class IITerminated
MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surger...
Reason: Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively...
Z-1092-2015February 18, 2015Portage, MI
Zimmer Dental Inc
Class IITerminated
GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered SwissPlus & SwissPlus Implant Systems Kits, Surgical, Complete, Catalog OPCST; Tapered Screw-Vent Implant System Surgical K...
Reason: The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex of the implant.
Z-1115-2015February 18, 2015Carlsbad, CA
Synthes, Inc.
Class IITerminated
Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Reason: Revision A of the Hemostatic Bone Putty Brochure (J10847A) was sent to sales consultants instead of Revision B (J10847B), which corrected an error in the indication statement.
Z-1094-2015February 18, 2015West Chester, PA
Zimmer, Inc.
Class IITerminated
Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots Catalog Number: 42-5279-002-00 thru 42-5279-009-04. Product Usage: The Persona TASPs are sterilizable instruments Int...
Reason: Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim...