FDA Medical Device Recalls (openFDA)
CoreLink LLC: CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
- Recall number
- Z-0954-2023
- Recalling firm
- CoreLink LLC
- Product
- CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
- Status
- Terminated
- Initiated
- 2022-10-20
- Posted
- 2023-01-12
- Terminated
- 2024-08-20
- Reason
- Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
- Root 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
- 18 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI M725AT32080, Lot Codes: SM135217, SM129260
- 510(k) numbers
- ["K171519"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3006494201
- Firm city
- Fenton
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28