Class 2 Device Recall CoreLink, LLC, FLXFIT

• Date Initiated by Firm: October 20, 2022
• Date Posted: January 12, 2023
• Recall Status: Terminated on August 20, 2024
• Recall Number: Z-0954-2023
• Recall Event ID: 91109
• 510(K)Number: K171519
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• Product: CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
• Code Information: UDI/DI M725AT32080, Lot Codes: SM135217, SM129260
• Recalling Firm/ Manufacturer: CoreLink LLC; 2072 Fenton Logistics Park; Fenton MO 63026-2504
• For Additional Information Contact: Amanda Gipperich; 888-349-7808
• Manufacturer Reason for Recall: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
• FDA Determined Cause: Process control
• Action: CoreLink initiated their recall by telephone to the physicians on 10/20/2022. The firm followed with a letter sent by FedEx. The letter explained the problem and the potential risk for health: "Potential Risks to Health: Please be aware that our records indicate your practice may have used one or more of the affected AT3208 devices (as shown in the table above), and that patients implanted with a FLXfit Expandable Interbody Spacer from affected lots should be monitored for: 1. MRI Safety: FLXfit devices, per current labeling, are not approved in the MR environment, and additionally, this labeling does not specify the presence of 17-4 Surgical Grade Stainless Steel. There is a possible risk of patient injury while scanning a patient implanted with FLXfit devices. The additional risk from the presence of steel is believed to be very low as published studies1,2,3, have shown negligible implant heating and no measurable device migration in an MR environment at 3 Tesla with stainless steel implants containing as much as 65% Iron content by weight and 31 times great mass than the affected devices1. 2. Implant Corrosion: There is a remote possibility for implant corrosion over time, which may result in localized pain, swelling, and tenderness, and may weaken the implant. If fusion does not occur, there is an increased potential for implant failure. CoreLink believes this is a remote possibility due in part to the passivation process performed in accordance with ASTM A967 that removes free iron particles on the surface of the affected component and creates a corrosion resistant passive surface layer. 3. Nickel Sensitivity: Patients with nickel sensitivities may experience non-life threatening4,5 allergic reactions to the implant material and implant removal may be necessary to alleviate these effects. We do not anticipate this issue to affect the structural integrity of the implant. The level of Nickel in the component by weight is .9% of the total mass, this is compara
• Quantity in Commerce: 18 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAX