CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Reported: January 18, 2023 Initiated: October 20, 2022 #Z-0954-2023
Product Description
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
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.
Details
- Recalling Firm
- CoreLink LLC
- Units Affected
- 18 units
- Distribution
- US Nationwide distribution.
- Location
- Fenton, MO
Frequently Asked Questions
What product was recalled? ▼
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208. Recalled by CoreLink LLC. Units affected: 18 units.
Why was this product recalled? ▼
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2023. Severity: Moderate. Recall number: Z-0954-2023.
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