CROSSROADS EXTREMITY SYSTEMS LLC
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (3)
Devices registered here (1)
- Driver, ProsthesisProduct code HWR (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4540
Recalls & enforcement
- Class IITerminated2019-09-19Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
- Class IITerminated2017-02-16Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
FDA inspections (3)
- VAI2022-08-26Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- VAI2019-08-02Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
- NAI2016-07-15No Action Indicated · Compliance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “CROSSROADS EXTREMITY SYSTEMS LLC (FEI 3020584246) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020584246-crossroads-extremity-systems-llc/
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