Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Reason: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Z-1512-2018May 2, 2018Mahwah, NJ
Keystone Dental Inc
Class IITerminated
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Reason: The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Z-1485-2018May 2, 2018Burlington, MA
Southern Implants, (Pty.) Ltd.
Class IITerminated
SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or...
Reason: The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
Z-1386-2018April 25, 2018Irene, Gauteng
Aesculap Implant Systems LLC
Class IIITerminated
Strauss Penis Clamp 130MM/General Instruments
Reason: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Z-1359-2018April 18, 2018Center Valley, PA
Neuropro Spinal Jaxx
Class IITerminated
Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative...
Reason: The implant size is incorrectly etched on the implant. The size listed on the box is correct.
Z-1350-2018April 18, 2018Burke, VA
W & H DentalWerk Burmoos GMBH - Site 1
Class IITerminated
Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
Reason: During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot...
Z-1351-2018April 18, 2018Burmoos
Aesculap Implant Systems LLC
Class IIITerminated
Doyen-Collin Mouth Gag 120MM/ General Instruments
Reason: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Z-1358-2018April 18, 2018Center Valley, PA
Aesculap Implant Systems LLC
Class IITerminated
DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
Reason: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. Updated cleaning and sterilization instructions.
Z-1291-2018April 11, 2018Center Valley, PA
Aesculap Implant Systems LLC
Class IITerminated
DS Titanium Ligation Clip, used in laparoscopic surgery
Reason: Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Added other contraindications. A publication from 2017 recommended Aesculap DS Clips for k...
Z-1290-2018April 11, 2018Center Valley, PA
Zimmer Biomet, Inc.
Class IITerminated
Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Mo...
Reason: Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
Z-1238-2018April 4, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 8005...
Reason: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Reason: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Z-1191-2018April 4, 2018Warsaw, IN
Encore Medical, Lp
Class IICompleted
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic ...
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500...
Z-1260-2018April 4, 2018Austin, TX
Zimmer Dental Inc
Class IITerminated
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Reason: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Z-1189-2018April 4, 2018Carlsbad, CA
Encore Medical, Lp
Class IICompleted
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shou...
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500...
Z-1259-2018April 4, 2018Austin, TX
SIE AG, Surgical Instrument Engineering
Class IITerminated
The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for u...
Reason: This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed...
Z-1272-2018April 4, 2018Port
Biomet, Inc.
Class IITerminated
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
Reason: During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw...
Z-1173-2018April 4, 2018Warsaw, IN
St. Jude Medical, Inc.
Class IITerminated
Proclaim DRG Implantable Pulse Generator, Model Number 3664
Reason: The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient ...
Z-1170-2018April 4, 2018Plano, TX
Cook Vascular Inc.
Class IITerminated
Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-t...
Reason: Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-c...
Z-1223-2018April 4, 2018Vandergrift, PA
Encore Medical, Lp
Class IICompleted
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shou...
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500...
Z-1258-2018April 4, 2018Austin, TX
Encore Medical, Lp
Class IICompleted
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shou...
Reason: It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500...
Z-1257-2018April 4, 2018Austin, TX
Zimmer Biomet, Inc.
Class IITerminated
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 0...
Reason: The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Z-1197-2018April 4, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Reason: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Z-1192-2018April 4, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Num...
Reason: Certain lots of the Phoenix Tibia Nail 3.5mm Inserter instruments are being recalled due to reports of fracturing and remaining in the device implant.