Z-0954-2023Class II

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Name: Z-0954-2023 CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Creator: CoreLink LLC
Published: 2022-10-20
License: https://open.fda.gov/license/

Corelink, LLC / initiated 2022-10-20 / Terminated / root cause: manufacturing process

FDA source

CoreLink LLC began a recall of CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 on 2022-10-20. FDA classified it as Class II and gives the reason as "Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0954-2023
Classification: Class II
Status: Terminated
Initiated: 2022-10-20
Posted: 2023-01-12
Terminated: 2024-08-20
Recalling firm: Corelink, LLC
Product: CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 18 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0954-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0954-2023	Class II	Terminated	Voluntary: Firm initiated	2023-01-18	2023-01-12

Product code MAX

K171519Class IIFLXfit™Expanding Orthopedics, Inc. / cleared 2017-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)