The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a ...
Reason: Due to Label/Pouch mix-up. Pouches incorrectly labeled. Incorrect shelf carton label or pouch label due to inadequate manufacturing line clearance. As a result of this labeling mi...
Z-0660-2022March 2, 2022Irvine, CA
Medtronic Vascular, Inc.
Class IIOngoing
Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endurant Stent Graft System Model/REF ENBF2313C120EE; ENBF2313C120EE; ENBF2313C145EE; ENBF2313C170EE; ENBF2316C120EE; ENBF...
Reason: Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during ...
Z-0657-2022March 2, 2022Santa Rosa, CA
DePuy Orthopaedics, Inc.
Class IITerminated
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
Reason: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Z-0632-2022February 16, 2022Warsaw, IN
DePuy Orthopaedics, Inc.
Class IITerminated
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
Reason: May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Z-0631-2022February 16, 2022Warsaw, IN
NuVasive Specialized Orthopedics, Inc.
Class IIOngoing
MAGEC 1 System
Reason: Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
Reason: Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5...
Reason: Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5...
Z-0512-2022January 26, 2022Andover, MA
Uromedica Inc.
Class IITerminated
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Reason: The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Z-0458-2022January 12, 2022Plymouth, MN
Howmedica Osteonics Corp.
Class IIOngoing
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalizati...
Reason: Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N:...
Z-0459-2022January 12, 2022Mahwah, NJ
Medtronic Neuromodulation
Class IIOngoing
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Reason: During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardi...
Z-0418-2022January 5, 2022Minneapolis, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Reason: The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR condition...
Z-0390-2022December 22, 2021Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IITerminated
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Reason: The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR condition...
Z-0391-2022December 22, 2021Mounds View, MN
Mentor Texas, LP.
Class IIOngoing
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired si...
Reason: Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Z-0367-2022December 22, 2021Irving, TX
NuVasive Specialized Orthopedics, Inc.
Class IIOngoing
NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10....
Reason: The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh...
Z-0319-2022December 8, 2021Aliso Viejo, CA
Medtronic Neuromodulation
Class IIOngoing
Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not fo...
Z-0293-2022December 1, 2021Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and Restor...
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not fo...
Z-0295-2022December 1, 2021Minneapolis, MN
Medtronic Neuromodulation
Class IIOngoing
Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
Reason: The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not fo...
Z-0294-2022December 1, 2021Minneapolis, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class IIOngoing
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization...
Reason: The processing of collected episode data may fail due to a software error.
Z-0282-2022December 1, 2021Mounds View, MN
Laboratoires Bodycad, Inc.
Class IITerminated
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
Reason: There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
Z-0244-2022November 24, 2021Quebec, N/A
OmniLife Science
Class IITerminated
OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for unceme...
Reason: The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Reason: 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm...
Reason: Packaged dental implant contains a different size then the size declared on the labeling.
Z-0197-2022November 10, 2021Westlake Village, CA
Implant Resource Inc
Class IIOngoing
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
Reason: Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
Z-0122-2022October 27, 2021Eagan, MN
Flower Orthopedics Corporation
Class IITerminated
Flower Drill Bit Kit 2.0 mm - intended to be used with solid 2.0mm screws and can be used with any plate that has been cleared as part of the Flower Small and Medium Implant Set and uses the small lo...
Reason: Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure