BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone...
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2232-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling b...
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2234-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone...
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2230-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone...
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2233-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone...
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2235-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2237-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2236-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone...
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2231-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2240-2018June 27, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
Reason: The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier fail...
Z-2241-2018June 27, 2018Warsaw, IN
Keystone Dental Inc
Class IITerminated
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit...
Reason: The implants are mislabeled.
Z-2162-2018June 20, 2018Burlington, MA
Zimmer Biomet, Inc.
Class IITerminated
Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty
Reason: One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly size...
Z-2177-2018June 20, 2018Warsaw, IN
Torax Medical, Inc.
Class IITerminated
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LXC-xx, sterile, Rx only. Labeled as: a. Product Code LXC-12; b. Product Code LXC-13; c. Product Code LXC-14; d...
Reason: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Z-2038-2018June 6, 2018Shoreview, MN
Torax Medical, Inc.
Class IITerminated
LINX Reflux Management System, Implant Clasp, 12-17 Bead, 0.7T, Product Code LX-xx, sterile, Rx only. Labeled as: a. Product Code LX-12; b. Product Code LX-13; c. Product Code LX-14; d. Pr...
Reason: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Z-2040-2018June 6, 2018Shoreview, MN
Torax Medical, Inc.
Class IITerminated
LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Labeled as: a. Product Code LXM-13; b. Product Code LXM-14; c. Product Code LXM-15; d...
Reason: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Z-2041-2018June 6, 2018Shoreview, MN
Torax Medical, Inc.
Class IITerminated
LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. P...
Reason: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Z-2037-2018June 6, 2018Shoreview, MN
Torax Medical, Inc.
Class IITerminated
LINX Reflux Management System, Implant Clasp, 13-17 Bead, 1.5T, Product Code LXMC-xx, sterile, Rx only. Labeled as: a. Product Code LXMC-13; b. Product Code LXMC-14; c. Product Code LXMC-15; ...
Reason: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
Z-2039-2018June 6, 2018Shoreview, MN
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
Reason: The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Z-1920-2018May 30, 2018Westlake Village, CA
Implant Direct Sybron Manufacturing, LLC
Class IITerminated
ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: ...
Reason: The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
Z-1917-2018May 30, 2018Thousand Oaks, CA
Spinal Elements
Class IIOngoing
AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion pr...
Reason: Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
Z-1912-2018May 30, 2018Marietta, GA
Zimmer Biomet, Inc.
Class IITerminated
Persona Cemented Tibial SZ PLT Size H Right, Item Number 42539908302 For use during orthopaedic surgery for implantation of a prosthesis.
Reason: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if crack...
Z-1808-2018May 23, 2018Warsaw, IN
Zimmer Biomet, Inc.
Class IITerminated
Persona Stemmed Tibial Provisional Size H Left, Item Number 42532108301 For use during orthopaedic surgery for implantation of a prosthesis.
Reason: There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if crack...
Z-1805-2018May 23, 2018Warsaw, IN
Kelyniam Global, Inc.
Class IITerminated
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Reason: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ...
Z-1870-2018May 23, 2018Collinsville, CT
Kelyniam Global, Inc.
Class IITerminated
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Reason: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ...
Z-1871-2018May 23, 2018Collinsville, CT
Kelyniam Global, Inc.
Class IITerminated
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Reason: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ...