Orthopedic Implant Cage Recalled for Incorrect Internal Material
Specific lots of CoreLink FLXFIT 15 orthopedic implant cages contain stainless steel internal components instead of the specified titanium alloy. The 18 affected units were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a material substitution in an orthopedic implant. No injuries or hospitalizations have been reported; however, the use of stainless steel instead of titanium in an implanted device constitutes a risk-of-harm product due to potential biocompatibility and structural integrity concerns.
Plain-English summary
CoreLink LLC has recalled specific lots of the FLXFIT 15 orthopedic implant cage (32MM X 8MM, Reference AT3208). Certain units contain internal components manufactured from stainless steel rather than the specified titanium alloy, which may affect biocompatibility and structural performance of the implant.
The recall affects 18 units distributed nationwide in the United States. The affected lot codes are SM135217 and SM129260, identified by UDI/DI M725AT32080.
Patients who have received this implant should contact their healthcare provider to determine if they received an affected unit and discuss appropriate follow-up care. Healthcare facilities should verify their inventory against the lot codes and notify CoreLink LLC and the FDA of any patients who received affected devices.
The recalled product
- Product
- CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
- Manufacturer
- CoreLink LLC
- Hazard
- material-substitution
- biocompatibility-risk
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI M725AT32080
- Lot Codes: SM135217
- SM129260
Distribution
Distributed nationwide across the United States.
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