Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
Reason: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Z-2038-2020May 27, 2020Laval, N/A
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2031-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2014-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Size 24x4mm, 18 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2017-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12 Product Usage: Used to simulate the ...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2028-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12 Product Usage: Used to simulate the ...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2016-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2018-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 12 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2015-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2023-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2019-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2011-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2025-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6 Product Usage: Used to simulate the he...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2009-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2029-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2027-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90111, UDI # 10888857108240, Size 24x8mm, 6 Product Usage: Used to simulate the he...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2010-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2030-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 10888857108349, Size 24x4mm, 12 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2013-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6 Product Usage: Used to simulate the he...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2022-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6 Product Usage: Used to simulate the he...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2021-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2024-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 10888857108288, Size 24x12mm, 6 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2012-2020May 27, 2020Leesburg, VA
K2M, Inc
Class IITerminated
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12 Product Usage: Used to simulate the h...
Reason: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Z-2026-2020May 27, 2020Leesburg, VA
Medtronic Navigation, Inc.
Class ITerminated
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imagin...
Reason: Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System...
Z-1995-2020May 27, 2020Louisville, CO
Bard Peripheral Vascular Inc
Class IIOngoing
BARD Access Systems PowerPort ClearVUE Slim Implantable Port With Smooth Septum and Attachable 6 F Polyurethane Open-Ended Single-Lumen Venous Catheter, Product #5676300 - Product Usage: All materials...
Reason: The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.